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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 15, 2005

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00200421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Double-Blind, Randomized, Multi-Center, Active Comparator, Five Treatment Study of the Effects of Nebivolol Compared to Atenolol on Cardiovascular Hemodynamics and Exercise Capacity in Patients With Mild to Moderate Hypertension

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Nebivolol and Atenolol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

August 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00200421

Responsible Party

Study ID Numbers ^ICMJE

NEB203

Study Sponsor ^ICMJE

Mylan Bertek Pharmaceuticals

Collaborators ^ICMJE

None

Investigators ^ICMJE

Study Director:

Betty S. Riggs, MD, MBA

Mylan Pharmaceuticals

Information Provided By

Mylan Bertek Pharmaceuticals

Verification Date

August 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP