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

Stopped early · Phase 3

Conditions studied: Hypertension

In brief

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)

Key facts

Study ID

NCT00547300

Run by

Forest Laboratories

People needed

49

Starts

2007-10-31

Expected to finish

2008-01-02

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Forest Research Institute 014 — Birmingham, Alabama, United States
• Forest Research Institute 028 — Beverly Hills, California, United States
• Forest Research Institute 054 — Encinitas, California, United States
• Forest Research Institute 025 — Roseville, California, United States
• Forest Research Institute 013 — Tustin, California, United States
• Forest Research Institute 053 — Vista, California, United States
• Forest Research Institute 052 — Walnut Creek, California, United States
• Forest Research Institute 033 — Westlake Village, California, United States
• Forest Research Institute 010 — DeLand, Florida, United States
• Forest Research Institute 019 — Holly Hill, Florida, United States
• Forest Research Institute 036 — Hollywood, Florida, United States
• Forest Research Institute 007 — Pembroke Pines, Florida, United States
• Forest Research Institute 009 — Atlanta, Georgia, United States
• Forest Research Institute 006 — Oxon Hill, Maryland, United States
• Forest Research Institute 027 — Las Vegas, Nevada, United States
• Forest Research Institute 050 — Salisbury, North Carolina, United States
• Forest Research Institute 039 — Wilmington, North Carolina, United States
• Forest Investigative Site 002 — Charleston, South Carolina, United States
• Forest Research Institute 032 — Greenville, South Carolina, United States
• Forest Research Institute 008 — Nashville, Tennessee, United States
• Forest Research Institute 003 — Carrollton, Texas, United States
• Forest Research Institute 012 — San Antonio, Texas, United States
• Forest Research Institute 048 — Sugar Land, Texas, United States
• Forest Research Institute 040 — Bountiful, Utah, United States

Full record on ClinicalTrials.gov

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