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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00775671 |
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
Condition | Intervention | Phase |
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Metabolic Syndrome |
Drug: nebivolol and placebo Drug: metoprolol and placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome |
Estimated Enrollment: | 48 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Nebivolol and placebo
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Drug: nebivolol and placebo
Placebo for 21 days and nebivolol 5 mg/day for 12 weeks
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2: Active Comparator
Metoprolol and placebo
|
Drug: metoprolol and placebo
Placebo for 21 days and metoprolol 100mg/day for 12 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For female subjects, the following conditions must be met:
Metabolic syndrome as defined by 3 or more of the following:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Contact: Loretta M Byrne | 615-322-2105 | loretta.byrne@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Nancy J Brown | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Ctr. Div. of Clinical Pharmacology ( Nancy J. Brown M/D. ) |
Study ID Numbers: | 080496 |
Study First Received: | October 17, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775671 |
Health Authority: | United States: Institutional Review Board |
Metoprolol succinate Nebivolol Metoprolol Insulin |
Vasodilator Agents Sympatholytics Neurotransmitter Agents Disease Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Syndrome Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |