|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
|
1: Experimental
Rosiglitazone
|
Drug: Rosiglitazone
tablet
|
|
2: Placebo Comparator
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: | Denver Research Institute ( Jane Reusch, MD ) |
| Study ID Numbers: | 101797, COMIRB NO: 03-755 |
| Study First Received: | August 8, 2008 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00733174 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
IGT |
|
Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Myocardial Ischemia Physiological Effects of Drugs Glucose Intolerance Vascular Diseases Arteriosclerosis |
Pharmacologic Actions Coronary Disease Hypoglycemic Agents Hyperglycemia Cardiovascular Diseases Glucose Metabolism Disorders Rosiglitazone Coronary Artery Disease |