Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01715818
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01715818
Study Brief:
Protocol Section:
NCT01715818