A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
Phase 3
Completed
- Conditions
- Cardiovascular Disease, Diabetes Mellitus Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT01715818
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1999
Inclusion Criteria
- Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
- Patients with glucose abnormalities based on one of the following A-B criteria:
A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
- Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines
Exclusion Criteria
- Current treatment with a thiazolidinedione (TDZ) or fibrate
- Prior intolerance to a TDZ or fibrate
- Previous participation in a trial with aleglitazar
- Other types of diabetes
- Inadequate liver, hematologic or renal function
- Symptomatic heart failure classified as NYHA class II-IV
- Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
- Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
- History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
- Currently scheduled for arterial revascularization procedures
- Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
- Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Aleglitazar aleglitazar -
- Primary Outcome Measures
Name Time Method Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC) 5 years
- Secondary Outcome Measures
Name Time Method Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) 5 years Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline) 5 years