A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00200473
- Lead Sponsor
- Mylan Bertek Pharmaceuticals
- Brief Summary
A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.
- Detailed Description
This study was a multi-center, multi-national, 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 and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
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 therapy or discontinuation of prior antihypertensive agents
- Pregnancy, nursing or women of childbearing age 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 (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline
- Secondary Outcome Measures
Name Time Method - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline - Response rate
Trial Locations
- Locations (1)
Mylan Pharmaceuticals Inc.
🇺🇸Morgantown, West Virginia, United States
Mylan Pharmaceuticals Inc.🇺🇸Morgantown, West Virginia, United States