Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
- Registration Number
- NCT00547300
- Lead Sponsor
- Forest Laboratories
- Brief 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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metoprolol ER Metoprolol ER Metoprolol ER 50 mg, 100 mg or 200 mg Nebivolol Nebivolol Nebivolol 5 mg, 10 mg or 20 mg
- Primary Outcome Measures
Name Time Method Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
- Secondary Outcome Measures
Name Time Method Peripheral Blood Pressure (BP) Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) Pulse Rate Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Trial Locations
- Locations (24)
Forest Research Institute 033
🇺🇸Westlake Village, California, United States
Forest Research Institute 025
🇺🇸Roseville, California, United States
Forest Research Institute 028
🇺🇸Beverly Hills, California, United States
Forest Research Institute 040
🇺🇸Bountiful, Utah, United States
Forest Research Institute 019
🇺🇸Holly Hill, Florida, United States
Forest Research Institute 052
🇺🇸Walnut Creek, California, United States
Forest Research Institute 032
🇺🇸Greenville, South Carolina, United States
Forest Research Institute 054
🇺🇸Encinitas, California, United States
Forest Research Institute 010
🇺🇸DeLand, Florida, United States
Forest Research Institute 053
🇺🇸Vista, California, United States
Forest Research Institute 050
🇺🇸Salisbury, North Carolina, United States
Forest Research Institute 039
🇺🇸Wilmington, North Carolina, United States
Forest Research Institute 003
🇺🇸Carrollton, Texas, United States
Forest Research Institute 027
🇺🇸Las Vegas, Nevada, United States
Forest Research Institute 008
🇺🇸Nashville, Tennessee, United States
Forest Research Institute 048
🇺🇸Sugar Land, Texas, United States
Forest Research Institute 014
🇺🇸Birmingham, Alabama, United States
Forest Research Institute 013
🇺🇸Tustin, California, United States
Forest Investigative Site 002
🇺🇸Charleston, South Carolina, United States
Forest Research Institute 006
🇺🇸Oxon Hill, Maryland, United States
Forest Research Institute 036
🇺🇸Hollywood, Florida, United States
Forest Research Institute 007
🇺🇸Pembroke Pines, Florida, United States
Forest Research Institute 012
🇺🇸San Antonio, Texas, United States
Forest Research Institute 009
🇺🇸Atlanta, Georgia, United States