The purpose of this study is to evaluate the effects of nebivolol on blood pressure and
heart rate in African American patients with hypertension.
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.
- African Americans with stage 1-2 hypertension
- Recent myocardial infarction or stroke
- Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy