A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | February 2010 |
| End Date: | November 2013 |
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)
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.
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.
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)
We found this trial at
185
sites
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