A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension
Information source: Mylan Bertek Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
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
Summary
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mylan Pharmaceuticals Inc., Morgantown, West Virginia 26505, United States
Additional Information
Starting date: May 2002
Ending date: August 2003
Last updated: December 15, 2005
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