Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145236

Enrollment

300

Registered

2005-09-05

Start date

2001-11-30

Completion date

2003-08-31

Last updated

2005-09-14

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

Conditions

Hypertension

Keywords

Nebivolol, Beta-Blocker

Brief summary

The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

Detailed description

This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

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

* Black adults with 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 * Contraindication to beta-blocker therapy

Design outcomes

Primary

Measure	Time frame
-Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline	—

Secondary

Measure	Time frame
-Change in sitting systolic blood pressure (SBP)	—
-Change in supine and standing DBP and SBP	—
-Response rate	—

Countries

United States

Outcome results

None listed

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