A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

Phase 3CompletedNCT00200434

Mylan Bertek Pharmaceuticals600 enrolled

Overview

The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Hypertension

Interventions

NebivololDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic. Exclusion Criteria: * Recent myocardial infarction or stroke * Contraindications to beta-blocker therapy

Locations (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

The change from baseline to week 12 in the average sitting DBP at trough.

Secondary Outcomes

Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR.

Data from ClinicalTrials.gov

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