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| Sponsored by: |
Mylan Bertek Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Bertek Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00145210 |
Purpose
The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nebivolol and Atenolol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Placebo- and Active-Controlled, Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension |
| Estimated Enrollment: | 630 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Despite the established benefits of beta-blockers, their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans (Amudha, 2003). This is a double-blind, randomized, placebo and active-controlled, multi-center, parallel group, forced titration study. Patients will be stratified across all treatment arms by age, gender, and diabetes status (history of diabetes mellitus vs no history of diabetes mellitus). The study consists of 3 periods: screening run-in, double-blind, randomized, forced titration and double-blind, washout period (only for patients who complete the double-blind, forced titration period and who are not participating in the long-term follow-up study). After a 14-28 day, single-blind, placebo controlled, run-in period, which includes washout (if applicable), eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks.
This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, West Virginia | |
| Mylan Pharmaceuticals Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Study Director: | Betty S. Riggs, MD, MBA | Mylan Pharmaceuticals |
More Information
| Study ID Numbers: | NEB310 |
| Study First Received: | September 1, 2005 |
| Last Updated: | March 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00145210 |
| Health Authority: | United States: Food and Drug Administration |
|
Nebivolol |
|
Vascular Diseases Nebivolol Atenolol Hypertension |
|
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
