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

Information source: Mylan Bertek Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol and Atenolol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Mylan Bertek Pharmaceuticals

Official(s) and/or principal investigator(s):
Betty S. Riggs, MD, MBA, Study Director, Affiliation: Mylan Pharmaceuticals


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

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

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

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

Starting date: May 2002
Last updated: December 15, 2005

Page last updated: August 23, 2015

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