Official Title: “Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

This study is 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. Uptitration 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.

Intervention(s) in this Clinical Trial

• Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
  • Nebivolol QD, Oral Admin Metoprolol ER QD, Oral Admin Hydrochlorothiazide, QD, Oral Admin

Primary Measures

• Patient responses on a Patient Symptoms Questoinnaire (PSQ)

Secondary Measures

• Peripheral blood pressure (BP), Central aortic pressure

Inclusion Criteria:

• Male or female, ambulatory outpatients 18-80 yo. Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
• 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
• Vision and hearing (hearing aid permissable) sufficient for compliance with testing procedures (i.e., with phone- and/or internet-based assessments)

Exclusion Criteria:

• Treatment with a beta-blocker or clonidine within 6 months of Screening
• 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
• Cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening
• History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening
• Use of antipsychotic medicaiton (e.g., dopanine 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
• History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547300

Study ID Number: NEB-MD-03

ClinicalTrials.gov Identifier: NCT00547300

Health Authority: United States: Food and Drug Administration