A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
Recruiting in Palo Alto (17 mi)
+621 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Hoffmann-La Roche
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
Research Team
CT
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
Inclusion Criteria
Adults >18 years of age
Type 2 diabetes mellitus
Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)
Treatment Details
Interventions
- Aleglitazar (Thiazolidinedione)
- Placebo (Drug)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AleglitazarExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01042769Thousand Oaks, CA
NCT01042769Plano, TX
NCT01042769Boston, MA
NCT01042769Fall River, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Trials
2482
Patients Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek