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| Sponsor: | Denver Research Institute |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Denver Research Institute |
| ClinicalTrials.gov Identifier: | NCT00733174 |
Purpose
Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data for exercise tolerance, coronary artery calcification and diabetes indicators.
| Condition | Intervention | Phase |
|---|---|---|
|
Impaired Glucose Tolerance |
Drug: Rosiglitazone Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Rosiglitazone
|
Drug: Rosiglitazone
tablet
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stacey Mitchell, BSN, RN | 303-399-8020 ext 2059 | stacey.mitchell@va.gov |
| United States, Colorado | |
| South Federal Family Practice | Recruiting |
| Denver, Colorado, United States, 80219 | |
| Contact: Annette Grissett, MA 303-934-2202 annetteg@roydurbin.com | |
| Contact: Stacey Mitchell, BSN, RN 303-399-8020 ext 2059 stacey.mitchell@va.gov | |
More Information
| Responsible Party: | Jane Reusch, MD, Denver Research Institute |
| ClinicalTrials.gov Identifier: | NCT00733174 History of Changes |
| Other Study ID Numbers: | 101797, COMIRB NO: 03-755 |
| Study First Received: | August 8, 2008 |
| Last Updated: | August 11, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
IGT |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Glucose Intolerance Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |