A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00200460
- Lead Sponsor
- Mylan Bertek Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.
- Detailed Description
This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 825
Inclusion Criteria
- 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
- Secondary hypertension
- Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy
- Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
- Secondary Outcome Measures
Name Time Method - Sitting SBP - Supine SBP and DBP - Standing SBP and DBP - Response rate - Correlation between plasma levels
Trial Locations
- Locations (1)
Mylan Pharmaceuticals Inc.
🇺🇸Morgantown, West Virginia, United States