Hypertension |
High Blood Pressure; Hypertension/High Blood Pressure |
Clinical Trial: Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
This study is currently recruiting patients.
Verified by Mylan Bertek Pharmaceuticals September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Nebivolol and Atenolol | Phase III |
MedlinePlus related topics: High Blood Pressure
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
Secondary Outcomes: Safety and tolerability
Expected Total Enrollment: 630
Study start: April 2005
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
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
Location and Contact Information
P J Guyton, BS 304-599-2595 Ext. 6693
West Virginia
Mylan Pharmaceuticals Inc., Morgantown, West Virginia, 26505, United States; Recruiting
P J Guyton, BS 304-599-2595 Ext. 6693 PJ.Guyton@mylanlabs.com
Multi-Center, Principal Investigator
Betty S. Riggs, MD, MBA, Study Director, Mylan Pharmaceuticals Inc.
More Information
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00145210
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06

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