Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
|
|
- Shanna Briggs
- 5 years ago
- Views:
Transcription
1 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. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: SB /007 Title: A randomized, double-blind trial to evaluate the efficacy and safety of fixed dose rosiglitazone/metformin combination therapy compared to both rosiglitazone and metformin monotherapies in drug naive type 2 diabetes mellitus subjects Rationale: In drug naïve type 2 diabetics, monotherapy is initially effective, but inadequate to maintain the majority of type 2 diabetics at glycemic target. Clinical studies with rosiglitazone (RSG) in combination with metformin (MET) have shown significant reductions in HbA1c that were sustained over time. Hence, RSG and MET in a fixed dose combination may offer a therapeutic advantage in control of glycemia. This study was performed to determine whether therapy with combination RSG/MET might prove more efficacious as first line therapy than either RSG or MET monotherapy. Phase: IIIb Study Period: 6Oct Dec2004 Study Design: This Phase IIIb study was a double-blind trial to evaluate efficacy and safety of combination RSG/MET compared to both RSG and MET monotherapies in drug naïve type 2 diabetics. This study was designed with a 2 week Screening period, followed by 32 weeks of treatment. Centres: The study was conducted in 90 centers in 7 countries: Australia (9), Brazil (2), Canada (28), Korea (3), Mexico (6), New Zealand (5) and the United States (37). Indication: Type 2 diabetes first line therapy. Treatment: RSG/MET dosing began with a total daily dose of 2mg/500mg and could be increased up to 8mg/2000mg in increments of 2mg/500mg. RSG treatment began with a total daily dose of 4mg and could be increased up to 8mg. MET dosing began with a total daily dose of 500mg and could be increased up to 2000mg in increments of 500mg. Matching placebo capsules were provided so that each treatment group would take the same number of capsules per day for each dose level and therapy was titrated to a Mean Daily Glucose (MDG) of 110mg/dL. Objectives: The primary objective of this study was to demonstrate the superiority of combination RSG/MET compared to both RSG and MET monotherapies with respect to mean change from baseline in HbA1c after 32 weeks of treatment in drug naïve type 2 diabetics. Primary Outcome/Efficacy Variable: Change in HbA1c from baseline to Week 32 Secondary Outcome/Efficacy Variable(s): The following were secondary efficacy endpoints: Change in FPG from baseline to Week 32. Proportion of HbA1c responders (i.e., reduction from baseline of 0.7% or HbA1c <7%) at Week 32. Proportion of FPG responders (i.e., reduction from baseline of 30mg/dL (1.7mmol/L) or <126mg/dL (7mmol/L) at Week 32. Change in fasting insulin, C-peptide, and fructosamine from baseline to Week 32. HOMA S, HOMA-B, and free fatty acids at Week 32. Proportion of subjects achieving defined levels of HbA1c and FPG at Week 32. Final dose at Week 32. C-reactive protein, PAI-1, adiponectin, albumin/creatinine ratio at Week 32. Lipid levels at Week 32 Proportion of subjects at each dose level (i.e., 1-4) at Week 32. Statistical Methods The primary efficacy endpoint was the change in HbA1c from baseline to Week 32 and the primary comparisons of interest were between combination RSG/MET and RSG and between combination RSG/MET and MET. For each of the two comparisons, the hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. No adjustment for multiple comparisons was made because the objective of the study was to show combination RSG/MET was superior to each of the monotherapy arms. Treatment differences were assessed using analysis of covariance (ANCOVA) including terms for gender, treatment, country and baseline HbA1c in the model, using the Intent-to-Treat (ITT) with last observation carried forward (LOCF) population. The ITT population consisted of all randomized subjects who received at least one dose of study medication and had at least one valid on-therapy observation for an efficacy variable. To assess the difference between treatment groups with regard to change from baseline to Week 32 in FPG, insulin, C-peptide and fructosamine, an analysis of covariance with terms for screening HbA1c, gender, treatment, country, and baseline was performed based on the ITT with LOCF population. The above mentioned ANCOVA model was also used to analyze the lipid ratios, total/hdl and LDL/HDL using the ITT without LOCF population. Analyses of HOMA-S, HOMA-B, CRP, albumin/creatinine ratio, adiponectin, free fatty acids and non-ratio lipid parameters were based on log-transformed data, and were performed in the ITT without LOCF population. To assess 1
2 the percent treatment difference with regard to each of these parameters at week 32, an analysis of covariance with terms for screening HbA1c, gender, treatment, country, and baseline measurement was performed. Differences between treatment groups in the proportion of HbA1c responders and HbA1c target achievers at week 32 was assessed by logistic regression with terms for baseline HbA1c, gender and treatment in the model. Differences between treatment groups in the proportion of FPG responders and FPG target achievers at Week 32 was assessed by logistic regression with terms for baseline FPG, screening HbA1c, gender and treatment in the model. The final dose was summarized and the mean calculated, using the ITT with LOCF population. The evaluation of safety data included summary of adverse events performed for the Safety population, which consisted of all randomized subjects who received at least one dose of double-blind study medication. Study Population: A subject was eligible for inclusion in this study if all of the following criteria applied: The subject was 18 to 70 years of age (at Screening) and gave written informed consent. The subject had a clinical diagnosis of type 2 diabetes mellitus according to guidelines set forth by the ADA, CDA or AACE and had a Quest HbA1c >7.5% and 11%, and FPG 270mg/dL (15mmol/L) at Screening. The subject had been treated with diet and/or exercise alone, or had not taken more than 15 days of OAD medication or insulin in the past 12 weeks. Subjects who met any of the following key exclusion criteria were not eligible for inclusion in the study: anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/dL for females, hemoglobinopathy, presence of clinically significant renal or hepatic disease (i.e., male subjects with serum creatinine 1.5mg/dL; female subjects with serum creatinine 1.4mg/dL; ALT, AST, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of the normal (ULN) reference range), unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment, systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on antihypertensive treatment, a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intraarticular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids was permissible), a prior history of hepatocellular reaction, severe edema or a medically serious fluid related event (e.g. heart failure) associated with troglitazone or any other thiazolidinedione (TZD), significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to TZDs, biguanides, or compounds with similar chemical structures, acute or chronic metabolic acidosis or a history of diabetic ketoacidosis, known to have severe lactose intolerance, a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and was receiving treatment for the active cancer. Number of Subjects: Planned, N Randomised, N Completed, n (%) 136 (88) 123 (80) 137 (86) Total Number Subjects Withdrawn, N (%) 19 (12) 31 (20) 22 (14) Withdrawn due to Adverse Events n (%) 2 (1) 3 (2) 5 (3) Withdrawn due to Lack of Efficacy n (%) 0 3 (2) 1 (<1) Withdrawn for other reasons n (%) 17 (5) 25 (3) 16 (1) Demographics N (Safety) Females: Males 66:89 67:87 66:93 Mean Age, years (SD) 50.1 (10.74) 51.5 (10.42) 50.6 (10.26) White, n (%) 83 (54) 90 (58) 94 (59) Primary Efficacy Results: Change in HbA1c from Baseline to Week 32 n Baseline: Mean±SD 8.86± ± ±1.045 Week 32: Mean±SD 6.59± ± ±1.390 Change from Baseline to Week 32: Mean±SD -2.27± ± ±1.326 Adjusted mean difference % CI , ,
3 p-value < Secondary Outcome Variable(s): Change in FPG (mg/dl) (ITT with LOCF), n Baseline: Mean ± SD ± ± ± Week 32: Mean ± SD ± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Protocol-Defined HbA1c Responders 140 (92.1) 131 (87.3) 127 (81.9) Odds Ratio to RSG & MET % CI , , 5.25 Protocol-Defined FPG Responders 141 (92.8) 109 (72.7) 118 (76.1) Odds Ratio to RSG & MET % CI , , 8.13 Change in Fasting Insulin (pmol/l), n Baseline: Mean±SD ± ± ± Week 32: Mean±SD ± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Change in C-peptide (nmol/l), n Baseline: Mean±SD 1.112± ± ± Week 32: Mean±SD 0.915± ± ± Change from Baseline: Mean±SD ± ± ± Adjusted mean difference % CI , , Change in Fructosamine (µmol/l), n Baseline: Mean±SD 343.8± ± ±67.44 Week 32: Mean±SD 254.4± ± ±63.43 Change from Baseline: Mean±SD -89.4± ± ±56.87 Adjusted mean difference % CI , , Percent Change in HOMA-B (%), n Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE (84.97, 99.74) (57.86, 69.36) (48.58, 60.25) Geometric mean (%) % CI , , Percent Change in HOMA-S (%), n
4 Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE (53.66, 70.19) (29.52, 42.66) (30.60, 41.90) Geometric mean (%) % CI , , C-Reactive Protein (µg/ml), n Baseline: geometric mean (CV %) 4.50 ( ) 3.55 ( ) 3.75 ( ) Week 32: geometric mean (CV %) 2.05 ( ) 2.28 ( ) 2.19 ( ) % Change from Baseline: geometric mean (GM -SE, GM +SE) , , , geometric mean % CI , , 3.90 Albumin/Creatinine Ratio at Week 32, n Baseline: geometric mean (CV %) ( ) ( ) ( ) Week 32: geometric mean (CV %) ( ) ( ) ( ) % Change from Baseline: geometric mean (GM -SE, GM +SE) , , , % Difference between combination RSG/MET and geometric mean % CI , , Adiponectin, n Baseline: geometric mean (CV %) 5.21 (58.864) 5.02 (57.174) 5.04 (55.881) Week 32: geometric mean (CV %) (59.713) 5.46 (55.826) (66.765) % Change from Baseline: geometric mean (GM -SE, GM +SE) (137.97, ) 8.59 (5.60, 11.67) (155.31, ) geometric mean % CI , , 3.88 Free Fatty Acid: mg/dl, n Baseline: Geometric mean Week 32: Geometric mean % Change from Baseline to Week 32 Geometric mean (%) Geometric mean ±SE , , , Geometric mean % CI , , Total Cholesterol (mg/dl), n Baseline, Geometric mean ( (19.76) (19.28) (26.63) Week 32, Geometric mean (19.82) (20.29) (27.88) 4
5 % Change from Baseline Geometric mean +/- SE -3.8, , , 7.2 geometric mean % CI - 2.6, , -3.1 HDL Cholesterol (mg/dl), n Baseline, Geometric mean 42.6 (21.76) 42.9 (23.79) 42.8 (24.50) Week 32, Geometric mean 45.0 (25.45) 43.0 (23.04) 44.1 (27.05) % Change from Baseline Geometric mean +/- SE 4.2, , , 4.7 geometric mean % CI - 1.2, , 6.4 LDL Cholesterol (mg/dl), n Baseline, Geometric mean ( (32.52) (33.88) (40.45) Week 32, Geometric mean (30.40) (35.18) (58.03) % Change from Baseline Geometric mean +/- SE -2.8, , , 8.4 % Difference between combination RSG/MET and monotherapy geometric mean % CI - 1.9, , 2.3 Triglycerides (mg/dl), n Baseline, Geometric mean ( (67.65) (62.27) (67.61) Week 32, Geometric mean (68.61) (58.34) (74.81) % Change from Baseline Geometric mean +/- SE -21.5, , , -0.9 % Difference between combination RSG/MET and monotherapy geometric mean % CI , , -4.1 TC/HDL-cholesterol ratio, n Baseline, mean±sd 4.858± ± ± Week 32, mean±sd 4.561± ± ± Change from Baseline, mean±sd ± ± ± Adjusted mean difference % CI , , LDL/HDL-cholesterol ratio, n Baseline, mean±sd 2.799± ± ± Week 32, mean±sd 2.686± ± ± Change from Baseline, mean±sd ± ± ± Adjusted mean difference % CI , , Final Dose Level at Week 32 N=152 N=150 N=155 Dose Level 1 2mg/500mg: 4 (3) 500mg:5 (3) 4mg: 4 (3) Dose Level 2 4mg/1000mg: 13 (9) 1000mg: 9 (6) 4mg: 5 (3) Dose Level 3 6mg/1500mg: 23 (15) 1500mg: 13 (9) 8mg: 12 (8) 5
6 Dose Level 4 8mg/2000mg: 112 (74) 2000mg: 123 (82) 8mg: 134 (86) Mean final dose (mg) 7.2 / Safety Results: An on therapy adverse event (AE) or serious adverse event (SAE) was defined as an AE reported between the first day of double-blind study medication until two days after the last date of double-blind study medication. Most Frequent Adverse Events On-Therapy n (%) n (%) n (%) Subjects with any AE(s), n(%) 126 (81) 113 (73) 125 (79) Nausea/vomiting 1 25 (16) 20 (13) 13 (8) Diarrhea 22 (14) 32 (21) 11 (7) Headache 17 (11) 18 (12) 16 (10) Dyspepsia 15 (10) 12 (8) 14 (9) Upper respiratory tract infection 14 (9) 11 (7) 13 (8) Dizziness 12 (8) 4 (3) 8 (5) Edema 2 10 (6) 4 (3) 11 (7) Nasopharyngitis 10 (6) 7 (5) 7 (4) Abdominal pain 8 (5) 10 (6) 11 (7) Arthralgia 8 (5) 4 (3) 11 (7) Flatulence 8 (5) 4 (3) 6 (4) Loose stools 7 (5) 9 (6) 2 (1) Constipation 7 (5) 6 (4) 10 (6) Abdominal pain upper 6 (4) 8 (5) 8 (5) Gastroenteritis 3 (2) 5 (3) 4 (3) Hypertension 3 (2) 5 (3) 4 (3) Influenza 2 (1) 3 (2) 10 (6) Terms for nausea and vomiting were combined. Terms for edema peripheral, edema, generalized edema and pitting edema were combined. Serious Adverse Events - On-Therapy n (%) [n considered by the investigator to be related to study medication] MET RSG RSG/MET Subjects with non-fatal SAEs, n (%) 5 (3) 5 (3) 5 (3) n (%) [related] n (%) [related] n (%) [related] Non-cardiac chest pain 1 (<1) [0] 0 1 (<1) [0] Appendicitis 1 (<1) [0] 0 0 Pneumonia 1 (<1) [0] 0 0 Atrial fibrillation 1 (<1) [0] 0 0 Uterine leiomyoma 1 (<1) [0] 0 0 Joint dislocation 1 (<1) [0] 0 0 Angina pectoris 0 1 (<1) [0] 0 Corneal ulcer 0 1 (<1) [0] 0 B-cell lymphoma 0 1 (<1) [0] 0 Deep vein thrombosis 0 1 (<1) [0] 0 Pulmonary embolism 0 1 (<1) [0] 0 Congenital anomaly 0 1 (<1) [0] 0 Cellulitis (<1) [0] Diverticulitis (<1) [0] Mycardial infarction (<1) [0] Dyspnea (<1) [0] Pancreatitis acute (<1) [0] Hypovolemia (<1) [0] Subjects with fatal SAEs, n (%)
7 Conclusion: See publication below. Publications: Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, September 2005, Athens, Greece. Date Updated: 22-Aug
Study No.: 49653/020 Title: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of
Study No.: 49653/020 Title: A Multicentre, Double-Blind, Parallel Group Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Rosiglitazone vs. Glibenclamide Therapy, When Administered
More informationStudy No.: Title: Rationale: Phase: 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 informationSupplementary Online Content
Supplementary Online Content Larsen JR, Vedtofte L, Jakobsen MSL, et al. Effect of liraglutide treatment on prediabetes and overweight or obesity in clozapine- or olanzapine-treated patients with schizophrenia
More informationSponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin/Metformin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLMF237A2309
More informationStudy 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 informationUMEC/VI vs. UMEC in subjects who responded to UMEC UMEC/VI vs. VI in subjects who responded to VI
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 informationClinical Trial Synopsis TL-OPI-518, NCT#
Clinical Trial Synopsis, NCT# 00225264 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl vs Glimepiride
More informationClinical 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 informationStudy 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 informationStudy 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 informationGSK Medicine: Study Number: Title: Rationale: Phase: 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 informationStudy Code: Date: 27 July 2007
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:
More informationIndication: Treatment: Objectives: Primary Outcome/Efficacy Variable: Secondary Outcome/Efficacy Variable(s): Statistical Methods:
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 informationSYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779)
TITLE OF THE STUDY / REPORT No. / DATE OF REPORT INVESTIGATORS / CENTERS AND COUNTRIES Clinical Study Report Protocol BC20779: Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:
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 informationThe 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 informationStudy 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 informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
Study No.: 29060/717 Title: A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of CR Intermittent Dosing (12.5 mg and 25 mg) for Premenstrual Dysphoric Disorder Rationale: In most trials investigating
More informationStudy No.: LOV Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary-
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 information23-Aug-2011 Lixisenatide (AVE0010) - EFC6014 Version number: 1 (electronic 1.0)
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of metformin
More informationThis was a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study.
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 informationStudy 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 informationSponsor / Company: Sanofi Drug substance(s): AMARYL M (1/250 mg) / HOE490
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationSponsor Novartis. Generic Drug Name. Valsartan and amlodipine Trial Indication(s) Hypertension Protocol Number CVAA489A2306 Protocol Title
Sponsor Novartis Generic Drug Name Valsartan and amlodipine Trial Indication(s) Hypertension Protocol Number CVAA489A2306 Protocol Title A randomized, double-blind, multi-center, active-controlled, parallel
More informationSYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only)
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20 mg) multicenter study of long-term glycemic control with rimonabant in treatment-naïve
More informationEfficacy/pharmacodynamics: 85 Safety: 89
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor/Company: Sanofi Drug substance:
More informationFull Novartis CTRD Results Template
Full Novartis CTRD Results Template Sponsor Novartis Generic Drug Name vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Protocol Number CLAF237A23138E1 Title A
More informationStudy 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 informationGSK Medicine: Study Number: Title: Rationale: Phase: 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 informationSYNOPSIS. Administration: subcutaneous injection Batch number(s):
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top
More informationStudy 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 informationThe 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 informationStudy 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 informationStudy 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 informationStudy 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 informationStudy 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 informationStudy 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 informationGSK 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 informationGalvus the most comprehensively studied DPP-4 inhibitor
Galvus the most comprehensively studied DPP-4 inhibitor! >7 000 patients enrolled in clinical studies! >4 00 patients exposed to Galvus >1 300 patients exposed 2 weeks >300 patients exposed for 104 weeks!
More informationClinical 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 informationThe 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 informationSYNOPSIS. Abbreviated Clinical Study Report. Study Code: RIMON_L_01031 Document Status: Synopsis V 2.1 Date: 16-Oct Title of the study:
SYNOPSIS Title of the study: Investigator(s): A 12-month multicentre, randomised, double-blind, placebo-controlled study with two parallel groups to assess the effects of rimonabant 20 mg in patients with
More informationClinialTrials.gov Identifier: HOE901_4020 Insulin Glargine Date: Study Code: This was a multicenter study that was conducted at 59 US sites
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Co-Primary Outcomes/Efficacy Variables:
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 informationSponsor Novartis. Generic Drug Name Fluvastatin. Therapeutic Area of Trial Dyslipidemia
Page 1 Sponsor Novartis Generic Drug Name Fluvastatin Therapeutic Area of Trial Dyslipidemia Approved Indication Therapeutic area and approved indications in Germany: Hypercholesterolemia (HC), combined
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See 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 informationStudy 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 informationSafety profile of Liraglutide: Recent Updates. Mohammadreza Rostamzadeh,M.D.
Safety profile of Liraglutide: Recent Updates Mohammadreza Rostamzadeh,M.D. Pancreatitis: Victoza post-marketing experience: spontaneous reports of pancreatitis For the majority of the cases, there is
More informationClinical Trial Synopsis TL-OPI-516, NCT#
Clinical Trial Synopsis, NCT#00225277 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus
More informationStudy 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 informationStudy 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 informationClinical 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 informationSponsor / Company: Sanofi Drug substance(s): Insulin Glargine. According to template: QSD VERSION N 4.0 (07-JUN-2012) Page 1
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationStudy 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 informationSCIENTIFIC STUDY REPORT
PAGE 1 18-NOV-2016 SCIENTIFIC STUDY REPORT Study Title: Real-Life Effectiveness and Care Patterns of Diabetes Management The RECAP-DM Study 1 EXECUTIVE SUMMARY Introduction: Despite the well-established
More informationThe promise of the thiazolidinediones in the management of type 2 diabetes-associated cardiovascular disease
The promise of the thiazolidinediones in the management of type 2 diabetes-associated cardiovascular disease Steve Smith, Group Director Scientific Affairs, Diabetes & Metabolism GlaxoSmithKline R & D
More informationThis 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 informationThe 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 informationStudy No.: ADF Title: Phase III study of adefovir dipivoxil (ADV) tablets in patients with compensated chronic hepatitis B -comparative study
Study No.: ADF105220 Title: Phase III study of adefovir dipivoxil () tablets in patients with compensated chronic hepatitis B -comparative study against lamivudine ()- Rationale: This study wass a confirmatory
More informationStudy No Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable(s):
Studies 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 informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective: Primary Outcome/Efficacy Variable:
Studies 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 informationThe 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 informationSponsor / Company: Sanofi Drug substance(s): Insulin Glargine (HOE901) Insulin Glulisine (HMR1964)
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationSponsor: Sanofi Drug substance(s): Lantus /insulin glargine. Study Identifiers: U , NCT Study code: LANTUL07225
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):
More informationStudy 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(For National Authority Use Only) Name of Study Drug: to Part of Dossier:
2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: ABT-335 Name of Active Ingredient: Page: ABT-335, A-7770335.115
More information2.0 Synopsis. Choline fenofibrate capsules (ABT-335) M Clinical Study Report R&D/06/772. (For National Authority Use Only) Name of Study Drug:
2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: Choline Fenofibrate (335) Name of Active Ingredient:
More informationHM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics>
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 informationStudy 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 informationTo assess the safety and tolerability in each treatment group.
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):
More informationNilotinib AEs (adverse events) in CML population:
Nilotinib AEs (adverse events) in CML population: The percentages below were taken from a randomized trial of nilotinib 300mg BID in newly diagnosed Ph+ CML patients (N=279) taken from the Tasigna 2017
More informationClinical Trial Results Summary Study EN3409-BUP-305
Title of Study: A 52-Week, Open-Label, Long-Term Treatment Evaluation of the Safety and Efficacy of BEMA Buprenorphine in Subjects with Moderate to Severe Chronic Pain Coordinating Investigator: Martin
More informationSponsor. Novartis. Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Type 2 diabetes.
Sponsor Page 1 Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLAF237A2308 Title A multicenter, randomized, double-blind,
More informationBRL /RSD-101C0D/1/CPMS-704. Report Synopsis
Report Synopsis Study Title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo- Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with
More informationThe 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 informationStudy 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 informationClinicalTrials.gov Identifier: NCT Sponsor/company: Sanofi-Aventis. Date: 08/02/ 2008
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Sanofi-Aventis ClinicalTrials.gov
More informationIndividual Study Table Referring to Part of Dossier: Use Only) Name of Study Drug:
2.0 Synopsis AbbVie Inc. Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: Adalimumab (Humira ) Page: Name of Active Ingredient: Adalimumab
More informationSponsor / Company: Sanofi Drug substance(s): HOE901-U300 (insulin glargine) According to template: QSD VERSION N 4.0 (07-JUN-2012) Page 1
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationStudy 2 ( ) Pivotal Phase 3 Study Top-Line Results. October 29, 2018
Study 2 (1002-047) Pivotal Phase 3 Study Top-Line Results October 29, 2018 Safe Harbor Forward-Looking Statements These slides and the accompanying oral presentation contain forward-looking statements
More informationThe 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 informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 2 December 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 2 December 2009 VICTOZA 6 mg/ml solution for injection in pre-filled pen Pack size of two 3 ml pens (CIP: 396 323-6)
More informationThe 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 informationegfr > 50 (n = 13,916)
Saxagliptin and Cardiovascular Risk in Patients with Type 2 Diabetes Mellitus and Moderate or Severe Renal Impairment: Observations from the SAVOR-TIMI 53 Trial Supplementary Table 1. Characteristics according
More informationIndividual Study Table Referring to Part of Dossier: Volume: Page:
Synopsis Abbott Laboratories Name of Study Drug: Paricalcitol Capsules (ABT-358) (Zemplar ) Name of Active Ingredient: Paricalcitol Individual Study Table Referring to Part of Dossier: Volume: Page: (For
More informationSecondary efficacy endpoints for Part 2, the Eltrombopag-Only Period, included the proportion of subjects who
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 informationSponsor Novartis. Generic Drug Name Pasireotide. Therapeutic Area of Trial Cushing s disease. Protocol Number CSOM230B2208E1
Sponsor Novartis Generic Drug Name Pasireotide Therapeutic Area of Trial Cushing s disease Protocol Number CSOM230B2208E1 Title Extension to a multicenter, open-label study to assess the safety and efficacy
More informationABC/3TC/ZDV ABC PBO/3TC/ZDV
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 informationSummary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, Nasdaq: DNDN
Summary of Phase 3 IMPACT Trial Results Presented at AUA Meeting Webcast Conference Call April 28, 2009 Nasdaq: DNDN PROVENGE sipuleucel-t is an autologous active cellular immunotherapy that activates
More informationDrug Class Monograph
Drug Class Monograph Class: Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drugs: alogliptin, alogliptin/metformin, Januvia (sitagliptin), Janumet (sitagliptin/metformin), Janumet XR (sitagliptin/metformin),
More informationStudy No.: Title: 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 informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Solomon SD, Uno H, Lewis EF, et al. Erythropoietic response
More informationGSK Medicine: Study Number: Title: Rationale: Phase: 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 informationThis 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 s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationSupplementary Table 1. Patient demographics and baseline characteristics (treated patients).
Supplementary Table 1. Patient demographics and baseline characteristics (treated patients). Placebo (n=188) 10 mg (n=186) 25 mg (n=189) Total (n=563) Gender, n (%) Male 75 (40) 97 (52) 84 (44) 256 (45)
More informationSponsor / Company: Sanofi Drug substance(s): Insulin Glargine. Study Identifiers: NCT
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationSynopsis. Adalimumab M Clinical Study Report R&D/09/060. (For National Authority Use Only) to Part of Dossier: Name of Study Drug:
Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Volume: (For National Authority Use Only) Name of Active Ingredient: Page: Title of Study: A Multi-Center,
More informationNew Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate
New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits
More information3/8/2011. Julie M. Sease, Pharm D, BCPS, CDE Associate Professor of Pharmacy Practice Presbyterian College School of Pharmacy
Summarize revisions to the 2011 American Diabetes Association clinical practice guidelines. Evaluate bromocriptine as a therapeutic option in the management of type 2 diabetes. Compare and contrast the
More information