Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
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ClinicalTrials.gov Identifier: NCT00145210 |
Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : March 7, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Nebivolol and Atenolol | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 630 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | April 2005 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

- Blood pressure
- Heart Rate
- Safety and tolerability

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145210
United States, West Virginia | |
Mylan Pharmaceuticals Inc. | |
Morgantown, West Virginia, United States, 26505 |
Study Director: | Betty S. Riggs, MD, MBA | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00145210 |
Other Study ID Numbers: |
NEB310 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | March 7, 2008 |
Last Verified: | September 2005 |
Nebivolol |
Hypertension Vascular Diseases Cardiovascular Diseases Atenolol Nebivolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |