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Clinical Trial: Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients with Mild to Moderate Hypertension
This study has been terminated.
|
Purpose
The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Nebivolol | 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, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients with Mild to Moderate Hypertension.
Further Study Details:
Primary Outcomes: To determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension
Secondary Outcomes: To determine, over a broad range of beta-blockers doses, the dose-response relationship of nebivolol on blood pressure in Black patients with mild to moderate hypertension
Expected Total Enrollment: 300
Secondary Outcomes: To determine, over a broad range of beta-blockers doses, the dose-response relationship of nebivolol on blood pressure in Black patients with mild to moderate hypertension
Expected Total Enrollment: 300
Study start: November 2001; Study completion: August 2003
This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline.
Exclusion Criteria:
- Recent myocardial infarction or stroke
- Contraindication to beta-blocker therapy
Location Information
West Virginia
Mylan Pharmaceuticals Inc., Morgantown, West Virginia, 26505, United States
Study chairs or principal investigators
Betty S. Riggs, MD, MBA, Study Director, Mylan Pharmaceuticals Inc.
More Information
Study ID Numbers: NEB202
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00145236
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00145236
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
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