Expired Study
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St. Louis, Missouri 63045


Purpose:

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 summary:

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.


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


NCT ID:

NCT00547300


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

St. Louis, Missouri 63045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 22, 2017

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