Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo

Size: px
Start display at page:

Download "Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo"

Transcription

1 (2001) 15, Nature Publishing Group All rights reserved /01 $ ORIGINAL ARTICLE Quality of life and cough on antihypertensive treatment: a randomised trial of eprosartan, enalapril and placebo EC Rake 1, E Breeze 2 and AE Fletcher 2 1 Institute for Cancer Research, London School of Hygiene and Tropical Medicine (LSHTM), London, UK; 2 Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine (LSHTM), London, UK The objective of this study was to compare the quality of life and incidence of dry cough with the angiotensin II antagonist eprosartan, the ACE-inhibitor enalapril, and placebo, in hypertensive patients with a history of ACEinhibitor cough. The study was a multicentre, randomised, double-blind, parallel group controlled trial. A total of 136 patients judged to have ACE-inhibitor cough during single-blind enalapril treatment which was lost during a subsequent placebo washout phase, were randomised to receive either eprosartan 300 mg twice daily, or enalapril 20 mg once daily, or placebo for 6 weeks. Self-completion questionnaires assessing quality of life and cough were examined at baseline and end of study. At study end point 23% of patients in the enalapril group and 5% in the eprosartan and placebo groups reported cough (which included definite, probable and possible coughs) (P 0.02). After adjusting for multiple comparisons, the eprosartan group was not significantly different from either placebo or enalapril. There were no significant differences in the Psychological General Wellbeing Index (PGWB). In conclusion the incidence of self-reported cough on eprosartan was similar to that on placebo, and lower than on enalapril but this difference was not significant when adjustments were made for multiple comparisons. There were no differences in quality of life. (2001) 15, Keywords: quality of life; dry cough; clinical trial; ACE-II inhibitor; ACE-I inhibitor; PGWB Introduction Persistent non-productive dry cough is the most common side effect of antihypertensive treatment with angiotensin-converting enzyme (ACE) inhibitors 1 and has been reported as the leading cause for discontinuation of this class of agents. 2 Cough associated with ACE inhibitors such as enalapril is thought to result from a non-specific pharmacological action related to inhibition of kininases. 3 Clinical research has shown that antihypertensive therapy with angiotensin II (A- II) receptor antagonists, which have a different mechanism of action than ACE inhibitors, is associated with a much lower incidence of persistent non-productive cough. In two studies of ACE coughers comparing the angiotensin-ii receptor antagonist losartan with the ACE inhibitor lisinopril, the incidence of cough was found to be significantly lower in the losartan group, Correspondence: Ms Elizabeth Breeze, Epidemiology Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. elizabeth.breeze Ishtm.ac.uk Received 20 December 2000; revised 3 June 2001; accepted 3 July 2001 compared to lisinopril. 3 6 Little is known about the more general aspects of quality of life (QOL) on ACE- II inhibitors. The present study was designed to compare the QOL and incidence of dry, non-productive cough in ACE-inhibitor sensitive patients treated with eprosartan, an A-II receptor antagonist, with that in patients treated with enalapril, or with placebo. Methods The present study was a randomised, double-blind, parallel group, controlled trial, involving 18 centres in the United States. The protocol was approved by the London School of Hygiene and Tropical Medicine (LSHTM) Ethics Committee and by each centre s local Ethics Review Committee. Written informed consent was obtained from all patients. Male and female patients, of at least 18 years of age, with mild to moderate hypertension and a history of ACE inhibitor induced cough were recruited for the trial. Patients had to be able to read and write in the local language of the centre. Figure 1 shows the study design. At screening, patients discontinued any previous antihypertensive treatment

2 QOL and cough on eprosartan, enalapril and placebo 864 Figure 1 Study design. before entering a 4- to 5-week, single-blind, placebo run-in period. Patients without a dry cough and with an average sitting diastolic blood pressure (DBP) of mm Hg at the last 2-weekly visits of the run-in period entered the 3- to 4-week, singleblind period of treatment with enalapril 20 mg daily (10 mg for the initial 3 days). Patients developing a persistent non-productive dry cough judged by the investigator to be related to the treatment entered a 2- to 4-week placebo washout period and those with no cough at the end of the washout period were randomly assigned (1:1:1) to double-blind treatment with eprosartan 300 mg twice daily (200 mg for the initial 3 days), enalapril 20 mg once daily (10 mg for the initial 3 days), or placebo for 6 weeks. Active and placebo forms of eprosartan and enalapril (double-dummy) were used during each period as appropriate to maintain blinding and to conceal period transitions. Throughout the study patients attended the clinic weekly or biweekly for blood pressure measurement and other vital signs. Patients experiencing any adverse side effects were also invited to return to the clinic between visits. Each patient completed both a QOL questionnaire, and a pulmonary questionnaire. Questionnaires were completed by the patient in privacy before they saw the clinician. The primary outcome from the QOL questionnaire was the Psychological General Wellbeing Index (PGWB). 7 This is a validated scale 8,9 of 22 items used to measure subjective wellbeing or distress with subscales for anxiety, depressed mood, positive wellbeing, self-control, general health and vitality. Higher scores reflect more positive wellbeing. The QOL questionnaire also contained six questions forming a sleep disturbance scale, 10,11 two questions measuring life satisfaction and one question on satisfaction with spouse. 12 Scores for each subscale were included in the analysis provided at least 80% of the items for that scale were answered. Where less than 20% of items were missing, the score was increased pro-rata as if patients had assigned their average score to the missing items. The primary pulmonary outcome was selfreported dry unproductive cough. The pulmonary questionnaire contained nine questions on pulmonary symptoms experienced during the previous 2 weeks and, for those who reported experiencing a persistent cough, a further nine questions. Three categories of cough were used for the primary analyses and are described in Table 1. Patients were asked to complete the QOL and pulmonary questionnaires at the beginning of the placebo run-in period, during the placebo washout phase just prior to randomisation, and at the last visit of the double-blind treatment. Those who withdrew before the end of the 6-week double-blind period were asked to complete the questionnaires at the visit at which they withdrew or, failing that, at a follow-up visit within 7 to 14 days. LSHTM were responsible for quality control checks, data entry, data processing and statistical analysis. The investigator completed a pulmonary questionnaire during every clinical assessment. This was similar to the patient-completed questionnaire but investigators also stated the probable cause of any cough reported by the patient and whether or not the patient was being withdrawn from the trial due to cough. The questionnaires were translated from English into Spanish for one centre in the study. It was hypothesised that 68% of those on enalapril Table 1 Category Persistent Dry/wet Duration of cough a Definite cough Yes Dry At least 14 days or caused to withdraw Probable cough Yes Dry Not known Possible cough Yes Not known As definite cough or No/not Dry As definite cough known a Duration defined as difference between end date and start date or, if cough still present at time of visit, as difference between visit date and start date.

3 and 33% of those on placebo would re-develop a dry unproductive cough during the double-blind treatment period, the percentage on eprosartan developing a cough being closer to that on placebo than to that on enalapril. With the expected marked difference in incidence of cough during the doubleblind treatment a substantial treatment effect size on the PGWB scales was anticipated, but it was recognised that the study (powered to detect a large percentage cough difference) would be less effective at detecting small differences in PGWB. With 45 patients per group the study would have 80% power at the 5% level to detect an effect size between treatments of 0.6, where effect size is defined as the difference between treatments in mean changes in scores from baseline to end point, divided by the pooled baseline standard deviation of the scores. 13 Analysis strategy The statistical analysis was performed without knowledge of the treatment codes. Using the intention-to-treat approach, QOL and pulmonary outcomes were compared at the end of study. This was the time at which the individual left the study, whether as a withdrawal or on completion. If no questionnaire was completed at the time the patient stopped medication then the latest questionnaire available was used, whether completed at follow-up or at a visit prior to the end of medication. For some patients the last QOL and pulmonary questionnaires were completed on different dates. Baseline was defined as the questionnaire completed at the last visit of the placebo washout period, determined by the patient having qualified for randomisation. Analyses were undertaken for those who had both a baseline and end point questionnaire. Changes in scores were analysed by Kruskal Wallis ANOVA. Chi-square tests were used to see if there were any between-group differences in the incidence of cough. Fisher s exact test was used to make pairwise comparisons, the comparisons of interest being eprosartan against placebo (to test the hypothesis of no difference) and eprosartan against enalapril (to see whether there was evidence of a difference). Significance of the two comparisons of interest were determined using the modified Bonferroni procedure due to Hochberg. 14 Under the Hochberg procedure if both P-values are less than 0.05 then both are statistically significant; if one is greater than 0.05 the other has to be less than to be considered statistically significant. Descriptive analyses were undertaken for the subsidiary QOL outcomes of sleep disturbance, satisfaction with life and satisfaction with spouse. Results A total of 231 patients were screened for the study. Of these, 136 patients were randomised: 45 patients each to enalapril and placebo, and 46 to the eprosar- QOL and cough on eprosartan, enalapril and placebo tan group. Four patients had insufficient information to analyse QOL; one because there was no end point questionnaire and a further three because the baseline questionnaires were completed while the patient was still in the washout phase. Thus QOL analyses covered 42 patients from the placebo group, 44 from the enalapril group and 46 from the eprosartan group. There were fewer self-completed pulmonary than QOL questionnaires for baseline and end point (41 for the placebo group and 39 each for the enalapril and eprosartan groups). Investigator-completed pulmonary questionnaires were completed for 45 patients in the placebo group, 44 in the enalapril group and 46 in the eprosartan group. At randomisation, there was no difference between the treatment groups for blood pressure or any of the demographic characteristics (Table 2). Fifteen percent of patients on eprosartan, 22% on enalapril and 24% on placebo withdrew from randomised treatment. The main reasons for withdrawal were adverse experiences and lack of efficacy. Withdrawals due to lack of efficacy occurred with similar frequency across the three treatment groups. Withdrawals resulting from adverse experiences occurred in 8.9% of the enalapril group, 4.4% of the placebo group and 2.2% of the eprosartan group. Of these, coughing was reported as the reason for withdrawal for two patients in the enalapril group and one patient in the eprosartan group. All but one patient completed withdrawal questionnaires. Quality of life The three treatment groups scored similarly for the PGWB scales at baseline. The P-values for the Kruskal Wallis ANOVA test of between-treatment changes indicate there were no significant effects between treatment groups (Table 3). Cough One definite cough and one probable cough were selfreported at baseline from the placebo group and epro- Table 2 Characteristics of those who had a baseline and end point QOL questionnaire Characteristic Placebo Enalapril Eprosartan (n = 42) (n = 44) (n = 46) Average age (years) Sex Male 20 (48%) 22 (50%) 27 (59%) Female 22 (52%) 22 (50%) 19 (41%) Mean DBP at baseline (mm Hg) Smoking history? Yes 5 (12%) 3 (7%) 4 (9%) No 37 (88%) 41 (93%) 42 (91%) Smokers cough? Yes 1 (2%) 0 (0%) 0 (0%) No 41 (98%) 44 (100%) 46 (100%) 865

4 QOL and cough on eprosartan, enalapril and placebo 866 Table 3 PGWB subscale scores at baseline and mean change between baseline and end point Scale (no. of items) Baseline Scores: Median (quartiles) Mean change Kruskal Wallis Placebo Enalapril Eprosartan Placebo Enalapril Eprosartan P-value Anxiety (5) n = 41 n = 39 n = 42 n = 41 n = 39 n = (22, 27) 25 (21, 28) 24 (22, 26) Depression (3) n = 41 n = 41 n = 45 n = 41 n = 41 n = (14, 18) 18 (15, 18) 17 (15, 18) Positive wellbeing (4) n = 38 n = 40 n = 43 n = 38 n = 40 n = (15, 21) 19.5 (15, 20) 18 (16, 21) Self-control (3) n = 41 n = 41 n = 46 n = 41 n = 41 n = (14, 18) 17 (16, 18) 17 (15, 18) General Health (3) n = 41 n = 40 n = 46 n = 41 n = 40 n = (12, 16) 15 (13.5, 16) 14 (12, 16) Vitality (4) n = 42 n = 43 n = 43 n = 42 n = 43 n = (15, 20) 19 (16, 21) 18 (14, 20) PGWB total (22) n = 42 n = 43 n = 46 n = 42 n = 43 n = (92, 116) 111 (100, 116) 104 (95, 119) sartan group respectively; neither of these baseline coughs were reported to the investigator. At the study end point, the numbers of self-reported definite dry coughs were five in the enalapril group, two in the placebo group and one in the eprosartan group; too few from which to draw any conclusions of statistical significance (Table 4). When all types of cough were included (definite plus probable plus possible), there were nine (23%) self-reported dry coughs in the enalapril group as compared with two (5%) coughs for patients on placebo or eprosartan (P 0.02 on a chisquared test). The incidence of cough was almost identical for eprosartan and placebo so eprosartan appeared to be no worse than placebo; the P-value for the difference between eprosartan and enalapril using Fisher s exact test was Under Hochberg s formula this is not statistically significant. Overall, investigators reported coughs for more people (n 19) than patients did (n 13). The number of investigator-reported definite dry coughs were three in the enalapril group as compared with one in each of the other two groups. When all types of cough were included (definite plus probable plus possible), there were 11 coughs in the enalapril group, five in the eprosartan group and three in the placebo group (P 0.039, ). Neither pairwise comparison involving eprosartan was statistically significant (P 0.48 for eprosartan against placebo and P 0.09 for eprosartan against enalapril). Table 4 Prevalence of self-assessed cough at study end point Cough Placebo Enalapril Eprosartan Chi-square categorisation (n = 41) (n = 39) (n = 39) P-value Definite dry cough Probable dry cough Possible dry cough All coughs P = 0.02 Secondary outcome measures There was a very slight improvement in measures of central tendency between baseline and end point across all three groups for life satisfaction. The mean scores for spouse satisfaction and sleep disturbance were similar for both baseline and study end point (not shown), and provide no indication of any treatment effect. Blood pressure control Patients responded to treatment if, at study end point, the mean sitting DBP was 90 mm Hg or less, or between 90 and 100 mm Hg, having decreased from baseline by at least 10 mm Hg. By study end point 54% of patients in the eprosartan group responded to treatment compared with 41% in the enalapril group and 25% the placebo group. Eprosartan had a statistically significant greater response rate than placebo (P 0.004) but not than enalapril. Discussion There were no significant differences between enalapril, eprosartan or placebo in their effects on PGWB in the present trial. The original study hypotheses of large differences in QOL between treatments were based on the assumption that there would be a high proportion of coughers in the enalapril group (68%) as compared to the eprosartan or placebo groups (33%). The numbers and percentages of coughers at end point were markedly less than anticipated. The percentage of coughs at study end point was 23% for the enalapril group (which included both probable and possible coughs) as against 5% for eprosartan and placebo. In trials of similar design to the present study much higher percentages of people were reported with coughs. In one trial the percentages were 72% on lisi-

5 nopril and 29% on losartan; 3 5 in the other trial the percentages were 87.5% and 36.7%. 15 There was also a marked difference in another trial which compared the effects of losartan, lisinopril and metolazone on patients with a history of ACE inhibitor-related cough (18% on losartan against 97% on lisinopril), although the threshold for cough detection was lowered for the double-blind phase of the study. 6 The reason for the unexpectedly low number of coughs at end point in the present study are unknown. One possible explanation is that patients treated as eligible for the double-blind treatment may have been less severely affected during the challenge period than those in the losartan trials. The data collected at the end of the enalapril challenge period provides some support for this suggestion. At this point the investigator judged all (subsequently) randomised patients to have an ACE- 1 induced cough. However, reference to self-completion data at this point reveals that only one-half to two-thirds of all randomised patients reported a definite cough and therefore non- ACE coughers may have been included in the trial. Perhaps the challenge-dechallenge study design may modify patients responses to subsequent ACE- 1 exposure. This suggestion is supported by the findings of Reisin and Schneeweiss 16 who reported the disappearance of ACE-1 induced cough after continued treatment in approximately one-half of their patients. In another report by the same authors, 64% of patients with ACE-1 associated cough reported cough disappearance, attenuation or intermittence while still on ACE inhibitors. 17 Furthermore, the high percentage of coughs in one of the losaratan trials 3 5 was achieved with a higher proportion of women in the trial (65%), who tend to develop or report cough (or both) more often than men Primary and secondary QOL outcomes were not statistically significantly different across the three treatment groups. The study had the power to detect effect sizes of 0.6 or more. In this study, between-treatment effect sizes were insignificant. For the total PGWB index the between treatment effect size for eprosartan vs placebo was 0.03 ( 0.29, 0.26) and for eprosartan versus enalapril was 0.08 ( 0.32, 0.17). The QOL analysis showed little difference among the three regimens. Acknowledgements The project was funded by Smithkline Beecham Pharmaceutical Inc (since merged into GlaxoSmithkline). References 1 Fletcher AE, Palmer AJ, Bulpitt CJ. Cough with angiotensin converting enzyme inhibitors: how much of a problem? J Hypertens 1994; 12 (Suppl 2): S43 S47. 2 Yeo WW, Ramsay LE. Persistent dry cough with enala- QOL and cough on eprosartan, enalapril and placebo pril: incidence depends on method used. J Hum Hypertens 1990; 4: Lacourcière Y et al, and the Losartan Cough Study Group. Effects of modulators of the renin-angiotensinaldosterone system on cough. J Hypertens 1994; 12: Ramsay LE, Yeo WW, on behalf of the Losartan Cough Study Group. ACE inhibitors, angiotensin II antagonists and cough. J Hum Hypertens 1995; 9 (Suppl 5): S51 S54. 5 Ramsay LE, Yeo WW, on behalf of the Losartan Cough Study Group. Double-blind comparison of losartan, lisinopril and hydrochlorothiazide in hypertensive patients with a previous angiotensin converting enzyme inhibitor-associated cough. J Hypertens 1995; 13 (Suppl 1): S73 S76. 6 Chan P et al. Double-blind comparison of losartan, lisinopril, and metolazone in elderly hypertensive patients with previous angiotensin-converting enzyme inhibitor-induced cough. J Clin Pharmacol 1997; 37: Dupuy HJ. The Psychological General Wellbeing Index. In: Wenger NK, Mattson ME, Furberg CD, Eliason J (eds). Assessment of Quality of Life in Clinical Trials of Cardiovascular Therapies. Le Jacq: New York, 1984, pp Wiklund I, Halling K, Lngström G. The Psychological General Wellbeing Index (PGWB), a reliable tool for use in cross-cultural multicentre clinical trials (abstract). Qual Life Res 1995; 4: Badia X, Gutiérrez F, Wiklund I, Alonso J. Validity and reliability of the Spanish version of the Psychological General Wellbeing Index. Qual Life Res 1996; 5: Bulpitt CJ, Fletcher AE. Measurements of quality of life in hypertension: a practical approach. Br J Clin Pharmacol 1990; 30: Crown S, Crisp AH. A short diagnostic self-rating scale for psychoneurotic patients. Br J Psychiatr 1966; 112: Developed in the Rand Corporation, Santa Monica, California. 13 Kazis LE, Anderson JJ, Meenan RS. Effect sizes for interpreting changes in health statistics. Med Care 1989; 27: Hochberg Y. A sharper Bonferroni procedure for multiple tests. Biometrika 1988; 75: Paster RZ et al. Use of Iosartan in the treatment of hypertensive patients with a history of cough induced by antiotensin-converting enzyme inhibitors. Clin Ther 1998; 20: Reisin L, Schneeweiss A. Complete spontaneous remission of cough induced by ACE-inhibitors during chronic therapy in hypertensive patients. J Hum Hypertens 1992; 6: Reisin L, Schneeweiss A. Spontaneous disappearance of cough induced by angiotensin-converting enzyme inhibitors (captopril or enalapril). Am J Cardiol 1992; 70: Israili ZH, Hall WD. Cough and angioneurotic oedema associated with angiotensin converting enzyme inhibitor therapy. Ann Intern Med 1992; 117: Yeo WW, Foster G, Ramsay L. Prevalence of persistent cough during long term enalapril treatment: controlled study versus nifedipine. QJMed1991; 293: Os I et al. Female sex as an important determination of lisinopril-induced cough (letter). Lancet 1992; 339:

Antihypertensive efficacy of olmesartan compared with other antihypertensive drugs

Antihypertensive efficacy of olmesartan compared with other antihypertensive drugs (2002) 16 (Suppl 2), S24 S28 2002 Nature Publishing Group All rights reserved 0950-9240/02 $25.00 www.nature.com/jhh compared with other antihypertensive drugs University Clinic Bonn, Department of Internal

More information

Drug Class Review on Angiotensin II Receptor Antagonists

Drug Class Review on Angiotensin II Receptor Antagonists Drug Class Review on Angiotensin II Receptor Antagonists Final Report Update 1 Evidence Tables February 2006 Original Report Date: September 2004 A literature scan of this topic is done periodically The

More information

The retinal renin-angiotensin system: implications for therapy in diabetic retinopathy

The retinal renin-angiotensin system: implications for therapy in diabetic retinopathy (2002) 16, S42 S46 2002 Nature Publishing Group All rights reserved 0950-9240/02 $25.00 www.nature.com/jhh : implications for therapy in diabetic retinopathy AK Sjølie 1 and N Chaturvedi 2 1 Department

More information

Treatment A Placebo to match COREG CR 20 mg OD + Lisinopril 10 mg OD (Days 1-7) Placebo to match COREG CR 40 mg OD + Lisinopril 10 mg OD (Days 8-14)

Treatment A Placebo to match COREG CR 20 mg OD + Lisinopril 10 mg OD (Days 1-7) Placebo to match COREG CR 40 mg OD + Lisinopril 10 mg OD (Days 8-14) The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

ORIGINAL INVESTIGATION. Medical Therapy, Symptoms, and the Distress They Cause

ORIGINAL INVESTIGATION. Medical Therapy, Symptoms, and the Distress They Cause ORIGINAL INVESTIGATION Medical Therapy, Symptoms, and the Distress They Cause Relation to Quality of Life in Patients With Angina Pectoris and/or Hypertension Norman K. Hollenberg, MD, PhD; Gordon H. Williams,

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

The hypertensive effects of the renin-angiotensin

The hypertensive effects of the renin-angiotensin Comparison of Telmisartan vs. Valsartan in the Treatment of Mild to Moderate Hypertension Using Ambulatory Blood Pressure Monitoring George Bakris, MD A prospective, randomized, open-label, blinded end-point

More information

The problem of uncontrolled hypertension

The problem of uncontrolled hypertension (2002) 16, S3 S8 2002 Nature Publishing Group All rights reserved 0950-9240/02 $25.00 www.nature.com/jhh The problem of uncontrolled hypertension Department of Public Health and Clinical Medicine, Norrlands

More information

High-dose monotherapy vs low-dose combination therapy of calcium channel blockers and angiotensin receptor blockers in mild to moderate hypertension

High-dose monotherapy vs low-dose combination therapy of calcium channel blockers and angiotensin receptor blockers in mild to moderate hypertension (2005) 19, 491 496 & 2005 Nature Publishing Group All rights reserved 0950-9240/05 $30.00 www.nature.com/jhh ORIGINAL ARTICLE High-dose monotherapy vs low-dose combination therapy of calcium channel blockers

More information

Angiotensin-Converting Enzyme Inhibitor-Induced Cough. ACCP Evidence-Based Clinical Practice Guidelines

Angiotensin-Converting Enzyme Inhibitor-Induced Cough. ACCP Evidence-Based Clinical Practice Guidelines Angiotensin-Converting Enzyme Inhibitor-Induced Cough ACCP Evidence-Based Clinical Practice Guidelines Peter V. Dicpinigaitis, MD, FCCP Background: A dry, persistent cough is a well-described class effect

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 7 January 2009

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 7 January 2009 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 7 January 2009 LERCAPRESS 10 mg/10 mg, film-coated tablets Pack of 30 (CIP code: 385 953-3) Pack of 90 (CIP code:

More information

SYNOPSIS. Publications No publications at the time of writing this report.

SYNOPSIS. Publications No publications at the time of writing this report. Drug product: TOPROL-XL Drug substance(s): Metoprolol succinate Study code: D4020C00033 (307A) Date: 8 February 2006 SYNOPSIS Dose Ranging, Safety and Tolerability of TOPROL-XL (metoprolol succinate) Extended-release

More information

Quality of life in chronic heart failure: cilazapril and captopril versus placebo

Quality of life in chronic heart failure: cilazapril and captopril versus placebo Heart 1998;79:593 598 593 Quality of life in chronic heart failure: cilazapril and captopril versus placebo C J Bulpitt, A E Fletcher, L Dössegger, A Neiss, T Nielsen, S Viergutz, on behalf of the Cilazapril-Captopril

More information

The management of hypertension has become

The management of hypertension has become AJH 1997;10:743 749 Additive Effects of Diltiazem and Lisinopril in the Treatment of Elderly Patients With Mild-to-Moderate Hypertension Paul Chan, Chun-Nan Lin, Brian Tomlinson, Tz-Hsin Lin, and Ying-Shiung

More information

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Page:

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER Volume: Page: SYNOPSIS Protocol No.: TOPMAT-MIG-303 EudraCT No.: 2005-000321-29 Title of Study: A double-blind, randomised, placebo-controlled, multicentre study to investigate the efficacy and tolerability of in prolonged

More information

Lisinopril 20 converting to losartan

Lisinopril 20 converting to losartan Search Lisinopril 20 converting to losartan Stop wasting your time with unanswered searches. lisinopril 40 mg to losartan conversion,cannot Find low price Best. Winds SSW at 10 to 20. Lisinopril 20 to

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Managing hypertension: a question of STRATHE

Managing hypertension: a question of STRATHE (2005) 19, S3 S7 & 2005 Nature Publishing Group All rights reserved 0950-9240/05 $30.00 www.nature.com/jhh ORIGINAL ARTICLE Managing hypertension: a question of STRATHE Department of Cardiovascular Disease,

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Double-blind comparison of eprosartan and enalapril on cough and blood pressure in unselected hypertensive

Double-blind comparison of eprosartan and enalapril on cough and blood pressure in unselected hypertensive Journal of Human Hypertension (1999) 13, 413 417 1999 Stockton Press. All rights reserved 0950-9240/99 $12.00 http://www.stockton-press.co.uk/jhh ORIGINAL ARTICLE Double-blind comparison of eprosartan

More information

Overview of the outcome trials in older patients with isolated systolic hypertension

Overview of the outcome trials in older patients with isolated systolic hypertension Journal of Human Hypertension (1999) 13, 859 863 1999 Stockton Press. All rights reserved 0950-9240/99 $15.00 http://www.stockton-press.co.uk/jhh Overview of the outcome trials in older patients with isolated

More information

Large therapeutic studies in elderly patients with hypertension

Large therapeutic studies in elderly patients with hypertension (2002) 16 (Suppl 1), S38 S43 2002 Nature Publishing Group All rights reserved 0950-9240/02 $25.00 www.nature.com/jhh Large therapeutic studies in elderly patients with hypertension Centro Clinico Profesional

More information

Study Center(s): The study was conducted at 39 study sites in Japan.

Study Center(s): The study was conducted at 39 study sites in Japan. SYNOPSIS Issue Date: 20 NOVEMBER 2012 Name of Sponsor/Company Janssen Pharmaceutical K. K. Name of Finished Product CONCERTA Name of Active Ingredient(s) Methylphenidate HCl Protocol No.: JNS001-JPN-A01

More information

PFIZER INC. GENERIC DRUG NAME and/or COMPOUND NUMBER: 5% Spironolactone Cream/ PF

PFIZER INC. GENERIC DRUG NAME and/or COMPOUND NUMBER: 5% Spironolactone Cream/ PF PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

ORIGINAL ARTICLE. JR Benz 1, HR Black 2, A Graff 3, A Reed 4, S Fitzsimmons 5 and Y Shi 5 1. Introduction

ORIGINAL ARTICLE. JR Benz 1, HR Black 2, A Graff 3, A Reed 4, S Fitzsimmons 5 and Y Shi 5 1. Introduction Journal of Human Hypertension (1998) 12, 861 866 1998 Stockton Press. All rights reserved 0950-9240/98 $12.00 http://www.stockton-press.co.uk/jhh ORIGINAL ARTICLE Valsartan and hydrochlorothiazide in patients

More information

Clinical Trial Results Database Page 1

Clinical Trial Results Database Page 1 Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Corporation Generic Drug Name Therapeutic Area of Trial Major Depressive Disorder (MDD) Approved Indication Treatment of major depressive

More information

AT 1 -receptor blockers: differences that matter

AT 1 -receptor blockers: differences that matter (2002) 16, S9 S16 2002 Nature Publishing Group All rights reserved 0950-9240/02 $25.00 www.nature.com/jhh AT 1 -receptor blockers: differences that matter Division of Cardiovascular Diseases, The Western

More information

Critical Appraisal Practicum. Fabio Di Bello Medical Implementation Manager

Critical Appraisal Practicum. Fabio Di Bello Medical Implementation Manager Critical Appraisal Practicum Fabio Di Bello Medical Implementation Manager fdibello@ebsco.com What we ll talk about today: DynaMed process for appraising randomized trials and writing evidence summaries

More information

Individual Study Table Referring to Part of the Dossier. Volume: Page:

Individual Study Table Referring to Part of the Dossier. Volume: Page: 1 SYNOPSIS (CR002878) Title of Study: The effect of on vasomotor symptoms in healthy postmenopausal women: a double-blind placebo controlled pilot study Investigators: Multiple, see Section 4, Investigators

More information

Study No.:MPX Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives:

Study No.:MPX Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods: Sample Size

Study No: Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods: Sample Size The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The CARI Guidelines Caring for Australasians with Renal Impairment. Blood Pressure Control role of specific antihypertensives

The CARI Guidelines Caring for Australasians with Renal Impairment. Blood Pressure Control role of specific antihypertensives Blood Pressure Control role of specific antihypertensives Date written: May 2005 Final submission: October 2005 Author: Adrian Gillian GUIDELINES a. Regimens that include angiotensin-converting enzyme

More information

CONSORT 2010 Statement Annals Internal Medicine, 24 March History of CONSORT. CONSORT-Statement. Ji-Qian Fang. Inadequate reporting damages RCT

CONSORT 2010 Statement Annals Internal Medicine, 24 March History of CONSORT. CONSORT-Statement. Ji-Qian Fang. Inadequate reporting damages RCT CONSORT-Statement Guideline for Reporting Clinical Trial Ji-Qian Fang School of Public Health Sun Yat-Sen University Inadequate reporting damages RCT The whole of medicine depends on the transparent reporting

More information

BRIEF COMMUNICATIONS. KEY WORDS: Ambulatory blood pressure monitoring, placebo effect, antihypertensive drug trials.

BRIEF COMMUNICATIONS. KEY WORDS: Ambulatory blood pressure monitoring, placebo effect, antihypertensive drug trials. AJH 1995; 8:311-315 BRIEF COMMUNICATIONS Lack of Placebo Effect on Ambulatory Blood Pressure Giuseppe Mancia, Stefano Omboni, Gianfranco Parati, Antonella Ravogli, Alessandra Villani, and Alberto Zanchetti

More information

Verapamil SR and trandolapril combination therapy in hypertension a clinical trial of factorial design

Verapamil SR and trandolapril combination therapy in hypertension a clinical trial of factorial design Br J Clin Pharmacol 1998; 45: 491 495 Verapamil SR and trandolapril combination therapy in hypertension a clinical trial of factorial design Juergen Scholze, 1 Peter Zilles 2 & Daniele Compagnone 2 on

More information

PFIZER INC. Study Initiation Date and Completion Dates: Information not available (Date of Statistical Report: 16 May 2004)

PFIZER INC. Study Initiation Date and Completion Dates: Information not available (Date of Statistical Report: 16 May 2004) PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

A study of losartan, alone or with hydrochlorothiazide vs nifedipine GITS in elderly patients with diastolic hypertension

A study of losartan, alone or with hydrochlorothiazide vs nifedipine GITS in elderly patients with diastolic hypertension Journal of Human Hypertension (1998) 12, 693 699 1998 Stockton Press. All rights reserved 0950-9240/98 $12.00 http://www.stockton-press.co.uk/jhh ORIGINAL ARTICLE A study of losartan, alone or with hydrochlorothiazide

More information

Reducing proteinuria

Reducing proteinuria Date written: May 2005 Final submission: October 2005 Author: Adrian Gillin Reducing proteinuria GUIDELINES a. The beneficial effect of treatment regimens that include angiotensinconverting enzyme inhibitors

More information

SYNOPSIS. Risperidone-R064766: Clinical Study Report RIS-INT-24 (FOR NATIONAL AUTHORITY USE ONLY)

SYNOPSIS. Risperidone-R064766: Clinical Study Report RIS-INT-24 (FOR NATIONAL AUTHORITY USE ONLY) SYNOPSIS Protocol No.: RIS-INT-24 Psychosis in Alzheimer s disease (PAD) analysis Title of Study: Risperidone in the treatment of behavioral disturbances in demented patients: an international, multicenter,

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Efficacy of Levetiracetam: A Review of Three Pivotal Clinical Trials

Efficacy of Levetiracetam: A Review of Three Pivotal Clinical Trials Epilepsia, 42(Suppl. 4):31 35, 2001 Blackwell Science, Inc. International League Against Epilepsy Efficacy of : A Review of Three Pivotal Clinical Trials Michael Privitera University of Cincinnati Medical

More information

A Placebo-Controlled, Forced Titration Study. Yves Lacourcière and Roland Asmar for the Candesartan/Losartan study investigators

A Placebo-Controlled, Forced Titration Study. Yves Lacourcière and Roland Asmar for the Candesartan/Losartan study investigators AJH 1999;12:1181 1187 A Comparison of the Efficacy and Duration of Action of Candesartan Cilexetil and Losartan as Assessed by Clinic and Ambulatory Blood Pressure After a Missed Dose, in Truly Hypertensive

More information

ARxCH. Annual Review of Changes in Healthcare. Entresto: An Overview for Pharmacists

ARxCH. Annual Review of Changes in Healthcare. Entresto: An Overview for Pharmacists Entresto: An Overview for Pharmacists David Comshaw, PharmD Candidate 2019 1 Gyen Musgrave, PharmD Candidate 2019 1 Suzanne Surowiec, PharmD, BCACP 1 Jason Guy, PharmD 1 1 University of Findlay College

More information

New Lipid Guidelines. PREVENTION OF CARDIOVASCULAR DISEASE IN WOMEN: Implications of the New Guidelines for Hypertension and Lipids.

New Lipid Guidelines. PREVENTION OF CARDIOVASCULAR DISEASE IN WOMEN: Implications of the New Guidelines for Hypertension and Lipids. PREVENTION OF CARDIOVASCULAR DISEASE IN WOMEN: Implications of the New Guidelines for Hypertension and Lipids Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Disclosure No relevant

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

MorphiDex (MS:DM) Double-Blind, Multiple-Dose Studies In Chronic Pain Patients

MorphiDex (MS:DM) Double-Blind, Multiple-Dose Studies In Chronic Pain Patients Vol. 19 No. 1(Suppl.) January 2000 Journal of Pain and Symptom Management S37 Proceedings Supplement NMDA-Receptor Antagonists: Evolving Role in Analgesia MorphiDex (MS:DM) Double-Blind, Multiple-Dose

More information

PFIZER INC. Study Initiation Date and Completion Dates: 09 March 2000 to 09 August 2001.

PFIZER INC. Study Initiation Date and Completion Dates: 09 March 2000 to 09 August 2001. PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

ALLHAT Role of Diuretics in the Prevention of Heart Failure - The Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial

ALLHAT Role of Diuretics in the Prevention of Heart Failure - The Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial 1 ALLHAT Role of Diuretics in the Prevention of Heart Failure - The Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial Davis BR, Piller LB, Cutler JA, et al. Circulation 2006.113:2201-2210.

More information

The CARI Guidelines Caring for Australasians with Renal Impairment. ACE Inhibitor and Angiotensin II Antagonist Combination Treatment GUIDELINES

The CARI Guidelines Caring for Australasians with Renal Impairment. ACE Inhibitor and Angiotensin II Antagonist Combination Treatment GUIDELINES ACE Inhibitor and Angiotensin II Antagonist Combination Treatment Date written: September 2004 Final submission: September 2005 Author: Kathy Nicholls GUIDELINES No recommendations possible based on Level

More information

Efficacy and safety of Olmesartan,Losartan, Valsartan, and Irbesartan in the Control of Essential Hypertension

Efficacy and safety of Olmesartan,Losartan, Valsartan, and Irbesartan in the Control of Essential Hypertension Efficacy and safety of Olmesartan,Losartan, Valsartan, and Irbesartan in the Control of Essential Hypertension Done by :Meznah zaid Al-mutairi Pharm.D Candidate Princess Nora Bint Abdul Rahman University

More information

Perioperative use of angiotensin blockade

Perioperative use of angiotensin blockade Perioperative use of angiotensin blockade Dr Fiona Chow on behalf of A/Prof Ian Fraser Epworth HealthCare 1 surgical_operation_with_surgeons_and_nurses_royalty_free_clipart_picture_100616-172691-620048.jpg

More information

Study No.: SAM40012 Title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1)

Study No.: SAM40012 Title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) Study No.: SAM40012 Title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate () (mcg strength) bd via DISKUS/ACCUHALER

More information

Drug Class Review on Calcium Channel Blockers

Drug Class Review on Calcium Channel Blockers Drug Class Review on UPDATED FINAL REPORT #1 April 2004 Marian S. McDonagh, PharmD Karen B. Eden, PhD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Table of

More information

9/17/2015. Reference: Ruschitzka F. J Hypertens 2011;29(Suppl 1):S9-14.

9/17/2015. Reference: Ruschitzka F. J Hypertens 2011;29(Suppl 1):S9-14. 0 1 2 Reference: Ruschitzka F. J Hypertens 2011;29(Suppl 1):S9-14. 3 Slide notes: Large trials such as ALLHAT, LIFE and ASCOT show that the majority of patients with hypertension will require multiple

More information

ClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT)

ClinicalTrials.gov Basic Results Data Element Definitions (DRAFT) ClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT) January 9, 2009 * Required by ClinicalTrials.gov [*] Conditionally required by ClinicalTrials.gov (FDAAA) May be required to comply with

More information

By Prof. Khaled El-Rabat

By Prof. Khaled El-Rabat What is The Optimum? By Prof. Khaled El-Rabat Professor of Cardiology - Benha Faculty of Medicine HT. Introduction Despite major worldwide efforts over recent decades directed at diagnosing and treating

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective: GSK Medicine: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) Study Number: 201147 Title: A IIIb, randomized, open-label study of the safety, efficacy, and tolerability of switching to a fixed-dose

More information

Drug Class Review on Calcium Channel Blockers FINAL REPORT

Drug Class Review on Calcium Channel Blockers FINAL REPORT Drug Class Review on Calcium Channel Blockers FINAL REPORT September 2003 TABLE OF CONTENTS Introduction 5 Scope and Key Questions 6 Methods 6 Literature Search 6 Study Selection 6 Data Abstraction 7 Validity

More information

Trough to peak ratio: current status and applicability

Trough to peak ratio: current status and applicability Journal of Human Hypertension (1998) 12, 55 59 1998 Stockton Press. All rights reserved 0950-9240/98 $12.00 REVIEW ARTICLE Trough to peak ratio: current status and applicability Department of Medicine

More information

SYNOPSIS (FOR NATIONAL AUTHORITY USE ONLY) INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER

SYNOPSIS (FOR NATIONAL AUTHORITY USE ONLY) INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER SYNOPSIS Protocol No.: RIS-USA-63 Psychosis in Alzheimer s disease (PAD) analysis Title of Study: A randomized, double-blind, placebo controlled study of risperidone for treatment of behavioral disturbances

More information

PhD Course in Biostatistics

PhD Course in Biostatistics PhD Course in Biostatistics Univ.-Prof. DI Dr. Andrea Berghold Institute for Medical Informatics, Statistics and Documentation Medical University of Graz andrea.berghold@medunigraz.at Content Introduction

More information

PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.

PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. PROPRIETARY DRUG NAME / GENERIC DRUG NAME: Lyrica / Pregabalin

More information

ANGIOTENSIN II RECEPTOR BLOCKERS: MORE THAN THE ALTERNATIVE PRESENTATION BY: PATRICK HO, USC PHARM D. CANDIDATE OF 2017 MENTOR: DR.

ANGIOTENSIN II RECEPTOR BLOCKERS: MORE THAN THE ALTERNATIVE PRESENTATION BY: PATRICK HO, USC PHARM D. CANDIDATE OF 2017 MENTOR: DR. ANGIOTENSIN II RECEPTOR BLOCKERS: MORE THAN THE ALTERNATIVE PRESENTATION BY: PATRICK HO, USC PHARM D. CANDIDATE OF 2017 MENTOR: DR. CRAIG STERN, PHARMD, MBA, RPH, FASCP, FASHP, FICA, FLMI, FAMCP RENIN-ANGIOTENSIN

More information

Phase 3 investigation of aprocitentan for resistant hypertension management. Investor Webcast June 2018

Phase 3 investigation of aprocitentan for resistant hypertension management. Investor Webcast June 2018 Phase 3 investigation of aprocitentan for resistant hypertension management Investor Webcast June 2018 The following information contains certain forward-looking statements, relating to the company s business,

More information

Summary ID# Clinical Study Summary: Study B4Z-JE-LYBC

Summary ID# Clinical Study Summary: Study B4Z-JE-LYBC CT Registry ID# 5285 Page 1 Summary ID# 5285 Clinical Study Summary: Study B4Z-JE-LYBC A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Hydrochloride

More information

hydrochlorothiazide in the treatment of moderate arterial

hydrochlorothiazide in the treatment of moderate arterial Br. J. clin. Pharmac. (1987), 23, 65S-69S Determination of the optimal dosage regimen of captopril + hydrochlorothiazide in the treatment of moderate arterial hypertension D. STERU1, M. CHILDS', S. LANCRENON',

More information

Critically Appraised Paper for Efficacy of occupational therapy for patients with Parkinson's disease: A randomized controlled trial

Critically Appraised Paper for Efficacy of occupational therapy for patients with Parkinson's disease: A randomized controlled trial Dominican University of California Dominican Scholar Occupational Therapy Critically Appraised Papers Series Occupational Therapy 2017 Critically Appraised Paper for Efficacy of occupational therapy for

More information

Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation

Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation Annex I Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation 1

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

SYNOPSIS (PROTOCOL WX17796)

SYNOPSIS (PROTOCOL WX17796) TITLE OF THE STUDY A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 52-week trial to assess the efficacy and safety of adjunct MMF to achieve remission with reduced

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI) PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

The renin-angiotensin-aldosterone system

The renin-angiotensin-aldosterone system Cardiology 59 Using ARBs in the elderly patient Effective management of hypertension can substantially reduce the risk of complications. The angiotensin receptor blockers are one of the latest anti-hypertensive

More information

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis

BRL /RSD-101RLL/1/CPMS-716. Report Synopsis Report Synopsis Study Title: A Multicenter, Open-label, Six-Month Extension Study to Assess the Long-term Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder (MDD) or Obsessive-Compulsive

More information

Trial No.: RIS-USA-102 Clinical phase: III

Trial No.: RIS-USA-102 Clinical phase: III SYNOPSIS Trial identification and protocol summary Company: Johnson & Johnson Pharmaceutical Research and Development, a division of Janssen Pharmaceutica, N.V. Finished product: Risperdal Active ingredient:

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Slide notes: References:

Slide notes: References: 1 2 3 Cut-off values for the definition of hypertension are systolic blood pressure (SBP) 135 and/or diastolic blood pressure (DBP) 85 mmhg for home blood pressure monitoring (HBPM) and daytime ambulatory

More information

State of the art treatment of hypertension: established and new drugs. Prof. M. Burnier Service of Nephrology and Hypertension Lausanne, Switzerland

State of the art treatment of hypertension: established and new drugs. Prof. M. Burnier Service of Nephrology and Hypertension Lausanne, Switzerland State of the art treatment of hypertension: established and new drugs Prof. M. Burnier Service of Nephrology and Hypertension Lausanne, Switzerland First line therapies in hypertension ACE inhibitors AT

More information

Clinical Trial Synopsis TL-OPI-525, NCT#

Clinical Trial Synopsis TL-OPI-525, NCT# Clinical Trial Synopsis, NCT#00762736 Title of Study: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCl (ACTOS

More information

SYNOPSIS. Issue Date: 25 Oct 2011

SYNOPSIS. Issue Date: 25 Oct 2011 SYNOPSIS Issue Date: 25 Oct 2011 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research & Development STELARA Ustekinumab Protocol No.: Title of Study: Study Name:

More information

Clinical Study Report SLO-AD-1 Final Version DATE: 09 December 2013

Clinical Study Report SLO-AD-1 Final Version DATE: 09 December 2013 1. Clinical Study Report RANDOMIZED, OPEN, PARALLEL GROUP, PHASE IIIB STUDY ON THE EVALUATION OF EFFICACY OF SPECIFIC SUBLINGUAL IMMUNOTHERAPY IN PAEDIATRIC PATIENTS WITH ATOPIC DERMATITIS, WITH OR WITHOUT

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Executive Summary. Different antihypertensive drugs as first line therapy in patients with essential hypertension 1

Executive Summary. Different antihypertensive drugs as first line therapy in patients with essential hypertension 1 IQWiG Reports Commission No. A05-09 Different antihypertensive drugs as first line therapy in patients with essential hypertension 1 Executive Summary 1 Translation of the executive summary of the final

More information

Hypertension Update 2009

Hypertension Update 2009 Hypertension Update 2009 New Drugs, New Goals, New Approaches, New Lessons from Clinical Trials Timothy C Fagan, MD, FACP Professor Emeritus University of Arizona New Drugs Direct Renin Inhibitors Endothelin

More information

Clinical Trial Synopsis TL , NCT#

Clinical Trial Synopsis TL , NCT# Clinical Trial Synopsis, NCT#00671398 Title of Study: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model

More information

Managing Hypertension in 2016

Managing Hypertension in 2016 Managing Hypertension in 2016: Where Do We Draw the Line? Disclosure No relevant financial relationships Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine baron@medicine.ucsf.edu

More information

Protocol Title: A Comparison of Interventions to Teach Melanoma Patients Skin Selfexamination

Protocol Title: A Comparison of Interventions to Teach Melanoma Patients Skin Selfexamination 1 2 3 4 Protocol Title: A Comparison of Interventions to Teach Melanoma Patients Skin Selfexamination Northwestern University Institutional Review Board: STU17005 Study Type: Interventional 5 Study Design:

More information

Sponsor. Novartis Pharmaceuticals Corporation Generic Drug Name. Agomelatine Therapeutic Area of Trial. Major depressive disorder Approved Indication

Sponsor. Novartis Pharmaceuticals Corporation Generic Drug Name. Agomelatine Therapeutic Area of Trial. Major depressive disorder Approved Indication Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Corporation Generic Drug Name Therapeutic Area of Trial Major depressive disorder Approved Indication Investigational drug Study

More information

Medicinal product no longer authorised SCIENTIFIC DISCUSSION. London, 22 November 2007 Product Name : Ariclaim Procedure No: EMEA/H/C/000552/II/0024

Medicinal product no longer authorised SCIENTIFIC DISCUSSION. London, 22 November 2007 Product Name : Ariclaim Procedure No: EMEA/H/C/000552/II/0024 European Medicines Agency Post-Authorisation Evaluation of Medicines for Human Use London, 22 November 2007 Product Name : Ariclaim Procedure No: EMEA/H/C/000552/II/0024 SCIENTIFIC DISCUSSION 1/7 EMEA

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Setting Community and hospital. The economic analysis was conducted in Ann Arbor, Michigan, USA.

Setting Community and hospital. The economic analysis was conducted in Ann Arbor, Michigan, USA. The cost-effectiveness of losartan versus captopril in patients with symptomatic heart failure Dasbach E J, Rich M W, Segal R, Gerth W C, Carides G W, Cook J R, Murray J F, Snavely D B, Pitt B Record Status

More information

ACE inhibitors are generally well-tolerated drugs, but

ACE inhibitors are generally well-tolerated drugs, but Effects of Candesartan on Cough and Bronchial Hyperresponsiveness in Mildly to Moderately Hypertensive Patients With Symptomatic Asthma Hiroshi Tanaka, MD; Shin Teramoto, MD; Kensuke Oashi, MD; Toyohiro

More information

Clinical Trial Synopsis

Clinical Trial Synopsis Clinical Trial Synopsis Title of Study: A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long-Term Administration of TAK-375 in Subjects With Chronic Insomnia Protocol Number: Name

More information

Management of Hypertension

Management of Hypertension Clinical Practice Guidelines Management of Hypertension Definition and classification of blood pressure levels (mmhg) Category Systolic Diastolic Normal

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 27 May 2009

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 27 May 2009 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 27 May 2009 RASILEZ HCT 150 mg/12.5 mg, film-coated tablets B/30 (CIP code: 392 151-6) RASILEZ HCT 150 mg/25 mg, film-coated

More information