A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension

Phase 2

Completed

• Conditions: Hypertension

• Registration Number: NCT00200421
• Lead Sponsor: Mylan Bertek Pharmaceuticals

Brief Summary

The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.

Detailed Description

This was a pilot, phase II, double-blind, randomized, muticenter, active-comparator, five treatment parallel group dosing and mechanistic study. The study consisted of two phases: 1) screen/washout/single-blind placebo run-in and 2) randomization/treatment. There was a minimum of five scheduled study visits.

Study Timeline

• Study Start: 2002-05
• Status Verified: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Submitted: 2005-12-15
• Last Update Posted: 2005-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• An average sitting diastolic blood pressure (DBP) 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 stopping prior antihypertensive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
The change in sub-maximal exercise duration at end of treatment compared to baseline.

Trial Locations

Locations (1)

Mylan Pharmaceuticals Inc.; 🇺🇸 Morgantown, West Virginia, United States