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Clinical Trials/NCT00200473
NCT00200473
Completed
Phase 3

A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Effects of Nebivolol on Safety and Efficacy in Patients With Mild to Moderate Hypertension

Mylan Bertek Pharmaceuticals1 site in 1 country800 target enrollmentSeptember 2001
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ConditionsHypertension
DrugsNebivolol

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypertension
Sponsor
Mylan Bertek Pharmaceuticals
Enrollment
800
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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

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 therapy or discontinuation of prior antihypertensive agents
  • •Pregnancy, nursing or women of childbearing age not using appropriate contraception

Outcomes

Primary Outcomes

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 Outcomes

  • - 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

Study Sites (1)

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