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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Mylan Bertek Pharmaceuticals
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
-Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
Secondary Outcomes
- -Change in sitting systolic blood pressure (SBP)
- -Change in supine and standing DBP and SBP
- -Response rate