A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients

A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00200460

Enrollment

825

Registered

2005-09-20

Start date

2001-09-30

Completion date

2003-03-31

Last updated

2005-09-20

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

Conditions

Hypertension

Keywords

Nebivolol, Hypertension, Beta-Blocker

Brief summary

The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

Detailed description

This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.

Interventions

DRUGNebivolol

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 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 treatment or discontinuation of current antihypertensive therapy * Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception

Design outcomes

Primary

Measure	Time frame
The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline	—

Secondary

Measure	Time frame
- Sitting SBP	—
- Supine SBP and DBP	—
- Standing SBP and DBP	—
- Response rate	—
- Correlation between plasma levels	—

Countries

United States

Outcome results

None listed

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