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

• Status: Terminated
• Trial end date: 2008-01-02
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Mylan Laboratories
• Treatments: Hydrochlorothiazide; Metoprolol; Nebivolol

Criteria

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