Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension
Information source: Forest Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Nebivolol, Metoprolol ER, Hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Forest Laboratories
Summary
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)
Clinical Details
Official title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Patient responses on a Patient Symptoms Questoinnaire (PSQ)
Secondary outcome: Peripheral blood pressure (BP), Central aortic pressure
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
For information regarding investigative sites, contact Forest Professional Affairs, St. Louis, Missouri 63045, United States
Additional Information
Starting date: October 2007
Ending date: October 2008
Last updated: February 5, 2008
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