| Trial ID: | L6604 |
| Source ID: | NCT00174993
|
| Associated Drug: |
Pioglitazone
|
| Title: |
Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes
|
| Acronym: |
PROactive
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization., At First Occurrence | Secondary: Time to All Cause Mortality., At occurrence|Time to Non-Fatal Myocardial Infarction., At occurrence|Time to Acute Coronary Syndrome., At occurrence|Time to Cardiac Intervention (including coronary artery bypass graft or percutaneous coronary intervention)., At occurrence|Time to Stroke., At occurrence|Time to Major Leg Amputation (above the ankle)., At occurrence|Time to Bypass Surgery, At occurrence|Time to Revascularization of the Leg., At occurrence|Time to Cardiovascular Mortality., At occurrence
|
| Sponsor/Collaborators: |
Sponsor: Takeda | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
4373
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2001-05
|
| Completion Date: |
2005-01
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-28
|
| Locations: |
Multiple Cities, Austria|Multiple Cities, Belgium|Multiple Cities, Czech Republic|Multiple Cities, Denmark|Multiple Cities, Estonia|Multiple Cities, Finland|Multiple Cities, France|Multiple Cities, Germany|Multiple Cities, Hungary|Multiple Cities, Italy|Multiple Cities, Latvia|Multiple Cities, Lithuania|Multiple Cities, Netherlands|Multiple Cities, Norway|Multiple Cities, Poland|Multiple Cities, Slovakia|Multiple Cities, Sweden|Multiple Cities, Switzerland|Multiple Cities, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00174993
|
