Expired Study
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Morgantown, West Virginia 26505


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.


Study summary:

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.


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


NCT ID:

NCT00145210


Primary Contact:

Study Director
Betty S. Riggs, MD, MBA
Mylan Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Morgantown, West Virginia 26505
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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