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

Mylan

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Nebivolol and Atenolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00200421

NEB203

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind