Expired Study
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Clinical Trial 11027

Johnson City, TN 37604

Study Summary:

Primary Objective
To determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and T2D.

Secondary Objectives

  • To evaluate the effects of aleglitazar on other clinical endpoints of cardiovascular risk

  • To evaluate the effects of aleglitazar on glycemic control, the lipoprotein profile, blood pressure, and biomarkers of cardiovascular risk

  • To evaluate the tolerability and long-term safety profile of aleglitazar (with special attention to known PPAR class adverse events such as fluid retention, heart failure, fractures, renal function, musculoskeletal adverse events and liver enzyme elevation)

Qualified Participants Must:

• Have type 2 diabetes and a recent ACS event
• Be 18 years of age or older
• Have known/established T2D or newly diagnosed T2D (confirmed prior to randomization according to the American Diabetes Association diagnostic criteria see protocol section 4.4)
• Have been hospitalized for an ACS event (see definition below) and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization). In case of any subsequent ACS event, procedure related MI or coronary bypass surgery occurring during the run-in period, randomization should occur when the patient’s conditions are deemed stable by the investigator but no later than 8 weeks from this new event. However, for these patients, the maximum allowed duration from index event to randomization is 12 weeks
• Have the ability and willingness to give written informed consent and to comply with the requirements of the study

Qualified Participants May Receive:

Free medical care, possible compensation for time and travel, and study medication provided at no charge to the patient.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.