NCT00200421CompletedPhase 2
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
Mylan Bertek Pharmaceuticals1 site in 1 country110 target enrollmentStarted: May 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mylan Bertek Pharmaceuticals
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
Study Overview
Brief Summary
The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.
Secondary Outcomes
- The change in sub-maximal exercise duration at end of treatment compared to baseline.
Investigators
Study Sites (1)
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