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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00200421

Enrollment

110

Registered

2005-09-20

Start date

2002-05-31

Completion date

2003-08-31

Last updated

2005-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Nebivolol, Atenolol, Exercise, Hypertension

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.

Interventions

DRUGNebivolol and Atenolol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.	—

Secondary

Measure	Time frame
The change in sub-maximal exercise duration at end of treatment compared to baseline.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026