Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
Information source: Mylan Bertek Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
The purpose of this study is to evaluate the effects of nebivolol on blood pressure and
heart rate in African American patients with hypertension.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Blood pressureHeart 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.
Eligibility
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
Locations and Contacts
Mylan Pharmaceuticals Inc., Morgantown, West Virginia 26505, United States
Additional Information
Starting date: April 2005
Last updated: March 6, 2008
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