A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension
The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
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|
- The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
- The change in sub-maximal exercise duration at end of treatment compared to baseline.
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||August 2003|
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.
|United States, West Virginia|
|Mylan Pharmaceuticals Inc.|
|Morgantown, West Virginia, United States, 26505|
|Study Director:||Betty S. Riggs, MD, MBA||Mylan Pharmaceuticals|