Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Blood pressure
- Heart Rate
- Safety and tolerability
| 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:
- African Americans with stage 1-2 hypertension
Exclusion Criteria:
- Recent myocardial infarction or stroke
- Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00145210
| United States, West Virginia | |
| Mylan Pharmaceuticals Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Study Director: | Betty S. Riggs, MD, MBA | Mylan Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00145210 History of Changes |
| Other Study ID Numbers: | NEB310 |
| Study First Received: | September 1, 2005 |
| Last Updated: | March 6, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mylan Bertek Pharmaceuticals:
|
Nebivolol |
Additional relevant MeSH terms:
|
Hypertension Cardiovascular Diseases Vascular Diseases Nebivolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists |
Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on March 03, 2015