|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00775671 |
Purpose
Test the hypothesis that nebivolol treatment improves fibrinolytic balance and insulin sensitivity compared to metoprolol treatment in individuals with metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
|
1: Active Comparator
Nebivolol and placebo
|
Drug: nebivolol and placebo
Placebo for 21 days and nebivolol 5 mg/day for 12 weeks
|
|
2: Active Comparator
Metoprolol and placebo
|
Drug: metoprolol and placebo
Placebo for 21 days and metoprolol 100mg/day for 12 weeks
|
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00775671 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Vasodilator Agents Sympatholytics Neurotransmitter Agents Disease Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nebivolol Cardiovascular Agents Antihypertensive Agents Metoprolol |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Syndrome Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |