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

This study has been completed.

First Received: September 12, 2005 Last Updated: December 15, 2005 History of Changes

Sponsors and Collaborators:	Mylan Bertek Pharmaceuticals None
Information provided by:	Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00200421

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Nebivolol and Atenolol	Phase II

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

Drug Information available for: Atenolol Nebivolol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	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

Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	110
Study Start Date:	May 2002
Estimated Study Completion Date:	August 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200421

Locations

United States, West Virginia
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, United States, 26505

Sponsors and Collaborators

Mylan Bertek Pharmaceuticals

None

Investigators

Study Director:

Betty S. Riggs, MD, MBA

Mylan Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	NEB203
Study First Received:	September 12, 2005
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00200421 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mylan Bertek Pharmaceuticals:

Nebivolol
Atenolol
Exercise
Hypertension

Study placed in the following topic categories:

Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Vascular Diseases
Nebivolol
Cardiovascular Agents
Antihypertensive Agents

Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Atenolol
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Sympatholytics
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Vascular Diseases
Nebivolol
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009