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Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145210
First Posted: September 5, 2005
Last Update Posted: March 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mylan Bertek Pharmaceuticals
September 1, 2005
September 5, 2005
March 7, 2008
April 2005
September 2007   (Final data collection date for primary outcome measure)
  • Blood pressure
  • Heart Rate
Same as current
Complete list of historical versions of study NCT00145210 on ClinicalTrials.gov Archive Site
Safety and tolerability
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
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
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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypertension
Drug: Nebivolol and Atenolol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
September 2007
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00145210
NEB310
Not Provided
Not Provided
Not Provided
Not Provided
Mylan Bertek Pharmaceuticals
Not Provided
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
Mylan Bertek Pharmaceuticals
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP