A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension

Mylan Bertek Pharmaceuticals1 site in 1 country825 target enrollmentSeptember 2001

ConditionsHypertension

DrugsNebivolol

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Mylan Bertek Pharmaceuticals
Enrollment: 825
Locations: 1
Primary Endpoint: The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

March 2003

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mylan Bertek Pharmaceuticals

Eligibility Criteria

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