Overview

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
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)

Exclusion Criteria:

- Estimated glomerular filtration rate <45 mL/min/1.73m2

- Concomitant treatment with a thiazolidinedione and/or fibrate

- Triglycerides >400 mg/dL

- Anaemia

- Symptomatic congestive heart failure classified as New York Heart Association (NYHA)
class II-IV (France and Germany: Symptomatic congestive heart failure classified as
NYHA class I-IV)