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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2003-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Keywords

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Nebivolol Atenolol Exercise Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nebivolol and Atenolol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Betty S. Riggs, MD, MBA

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Inc

Locations

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Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NEB203

Identifier Type: -

Identifier Source: org_study_id