Clinical Study Synopsis

Transcription

1 Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website or on the website hosted by the Pharmaceutical Research and Manufacturers of America (PhRMA). It is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labeling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare Pharmaceuticals Inc. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare Pharmaceuticals Inc. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer Healthcare Pharmaceuticals Inc. Study Number: NCT Study Phase: IIIb Official Study Title: Randomized, open-label 2-arm parallel design comparator study of the effect of Adalat XL compared to diltiazem (Tiazac XC) on proteinuria and blood pressure in patients with diabetes and mild to moderate hypertension, when used as an add-on to Avalide (angiotensin-receptor blocker (ARB) irbesartan and hydrochlorothiazide). Therapeutic Area: Cardiology/Coagulation Test Product Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: Reference Therapy/Placebo Reference Therapy: Nifedipine (Adalat XL, BAY a1040) nifedipine 20 mg, 30 mg, or 60 mg, oral The study consists of a 12 Week Run-In Period during which all subjects are stabilized on Avalide ; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day. Avalide will be taken each night throughout the 12 Week Run-In Period and treatment period. Then at the randomization visit, subjects will be randomized to receive either Adalat XL or Tiazac XC. Adalat XL will be provided at starting doses of 20 mg, 30mg, or 60 mg and Tiazac XC at 180 mg Dose and Mode of Administration: At screening all subjects will receive Avalide ; 300 mg/12.5 mg per day or 300 mg/25.0 mg per day). Avalide will be taken each night throughout the Run-In Period and treatment period. Then at the randomization visit, subjects will be randomized to receive either Adalat XL or Tiazac XC. Adalat XL will be provided at starting doses of 20 mg, 30mg, or 60 mg, and Tiazac XC at 180 mg Page 1 of 5

3 Duration of Treatment: This study was terminated by the Sponsor due to operational reasons. Fourteen subjects were consented, three subjects entered the run-in period and none was randomized. Studied period: Date of first subjects first visit: 12-NOV-2008 Date of last subjects last visit: 03-MAR-2009 Study Center(s): 14 centers in Canada of which 5 centers consented subjects Methodology: Indication/ Main Inclusion Criteria: This was a multi-center, randomized, open-label, 2 arm comparator trial using a PROBE design (prospective, randomized, open label, blinded end point evaluation). Diabetic nephropathy Hypertension Subjects included those who had a diagnose with diabetic nephropathy AND hypertension defined as a sitting diastolic blood pressure of > 80 mmhg or a systolic blood pressure of > 130 mmhg (Canadian Hypertension Society guidelines). At screening, subjects must have proteinuria between 0.8 to 5.0 g/day. At randomization, it must be between 0.8 to 3.0 g/day. The main inclusion criteria are: Subjects who are 18 and < 80 years of age Subjects who have been diagnosed with hypertension Subjects who are diagnosed with diabetes mellitus at least six months prior to study entry and are on stable medications for diabetes for at least one month prior to screening Subjects who have been and are currently treated with an ARB or ACEI (with or without hydrochlorothiazide) for at least four months prior to screening and are suitable to receive combination therapy with Avalide at 300 mg /12.5 mg per day or 300 mg/25.0 mg per day Subjects who have been diagnosed with diabetic nephropathy and a proteinuria of at least 0.8 g/day and not more than 5.0 g/day at screening. At randomization, proteinuria must be at least 0.8 g/day and not more than 3.0 g/day Page 2 of 5

4 Study Objectives: Overall: Evaluation Criteria: Primary: To compare the change in proteinuria (measured by 24 hr urine protein excretion) from randomization to Week 18 in response to Adalat XL vs.tiazac XC at doses required for blood pressure (BP) reduction to the target BP < 130/80 mmhg in subjects with diabetic nephropathy and hypertension Secondary: The percent of subjects reaching a BP target of < 130/80 mmhg at Week 18 in response to randomized treatment with Adalat XL vs. Tiazac XC, in addition to baseline Avalide therapy. The percent of subjects reaching a target of proteinuria of < 0.5 g/day at Week 18 in response to randomized treatment with Adalat XL vs. Tiazac XC therapy. The number and doses of anti-hypertensives used in the two treatment arms. The levels of urinary protein content, sodium content, and estimated Glomerular Filtration Rate (egfr), creatinine clearance, Urine Protein to Creatinine Ratio (UPCR), and Urine Sodium to Creatinine Ratio (UNaCR) in response to Adalat XL vs. Tiazac XC from randomization to end of study. The BP reduction one week after randomization in response to Adalat XL vs. Tiazac XC. Tolerability, by assessing rates of discontinuation. The rates of side effects, particularly edema. Change in index of glycemia (HbA1c) from screening to Week 18. Efficacy (Primary): Efficacy (Secondary): Safety: Pharmacokinetics: Other: Page 3 of 5

5 Statistical Methods: Efficacy (Primary) - if applicable: Efficacy (Secondary) - if applicable: Safety: Pharmacokinetics - if applicable: Other - if applicable: Number of Subjects: Assuming a dropout rate of 10% after randomization, it is estimated that 101 subjects should be randomized to each treatment arm. To ensure that a total of 202 subjects are available at randomization, it will be necessary to randomize at least 10 subjects at approximately 20 investigational sites Study Results Results Summary Subject Disposition and Baseline This study was terminated by the Sponsor due to operational reasons. Fourteen subjects were consented, three subjects entered the run-in period and none was randomized Results Summary Efficacy This study was terminated by the Sponsor. Fourteen subjects were consented, three subjects entered the run-in period and none was randomized Results Summary Safety Results Summary Pharmacokinetics Page 4 of 5

6 Results Summary Other Conclusion(s) This study was terminated by the sponsor due to operational reasons. Fourteen subjects were consented, 3 subjects had entered the run-in period, and no subject was randomized. Publication(s): Date Created or Date Last Updated: none 17-FEB-2010 Page 5 of 5