Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

Phase 3TerminatedNCT00547300

Forest Laboratories49 enrolled

Overview

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension

Interventions

Metoprolol ERDRUG

Metoprolol ER once daily, oral administration

NebivololDRUG

Nebivolol once daily, oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, ambulatory outpatients * History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine * SBP of 135-155 mm Hg and/or DBP of \>85 mm Hg at screening (Visit 1) * SBP of 140-165 mm Hg and DBP \> 90 mmHg at randomization (Visit 3) Exclusion Criteria: * Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1) * Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease) * Coronary artery disease requiring treatment with a calcium channel blocker or nitrates * Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1) * History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1) * Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants * Diabetes mellitus, type I or II * Participation in a previous investigational study of nebivolol at any time * Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1) * History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Locations (24)

Forest Research Institute 014

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score

The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

Time frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)

Secondary Outcomes

Peripheral Blood Pressure (BP)

Time frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Pulse Rate

Time frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Data from ClinicalTrials.gov

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