Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

Condition(s) targeted: Hypertension

Intervention: Nebivolol and Atenolol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mylan Bertek Pharmaceuticals

Official(s) and/or principal investigator(s):
Betty S. Riggs, MD, MBA, Study Director, Affiliation: Mylan Pharmaceuticals

The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Blood pressure

Heart Rate

Secondary outcome: Safety and tolerability

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mylan Pharmaceuticals Inc., Morgantown, West Virginia 26505, United States

Starting date: April 2005
Ending date: September 2007
Last updated: March 6, 2008