Clinical Trial Details
| Trial ID: | L5255 |
| Source ID: | NCT00225264 |
| Associated Drug: | Pioglitazone |
| Title: | Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease. |
| Acronym: | CHICAGO |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus |
| Interventions: | DRUG: Pioglitazone|DRUG: Glimepiride |
| Outcome Measures: | Primary: Absolute change from Baseline in carotid intima-media thickness., Weeks 24, 48 and Final Visit. | Secondary: Change from Baseline in carotid intima-media thickness., Weeks 24, 48 and Final Visit.|Change from Baseline in coronary artery calcium-volume score., At Final Visit|Change from Baseline in abdominal adipose tissue content and distribution., At Final Visit|Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction and nonfatal stroke, At each occurrence|Incidence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, carotid endarterectomy/stenting, hospitalization for unstable angina and hospitalization for CHF, At each occurrence |
| Sponsor/Collaborators: | Sponsor: Takeda |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 458 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2003-10 |
| Completion Date: | 2006-05 |
| Results First Posted: | |
| Last Update Posted: | 2012-02-28 |
| Locations: | Chicago, Illinois, United States |
| URL: | https://clinicaltrials.gov/show/NCT00225264 |
