Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal