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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200421
First received: September 12, 2005
Last updated: December 15, 2005
Last verified: August 2003
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Investigators
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Mylan Bertek Pharmaceuticals:
Nebivolol
Atenolol
Exercise
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Nebivolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013