A Phase 3B Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients with Stable Cardiovascular Disease and Glucose Abnormalities

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 0 人开始时间: 2013年6月26日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Male and female patients with established evidence of stable CVD defined as at least one of the following groups of criteria (A or B):
•A. Age ≥ 40 years with history of a prior CV event (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 the 2010 ADA criteria. Treatment may include diet alone, or any approved glucose-lowering therapies except for thiazolidinediones (TZDs)
•B. No fulfillment of criteria A but evidence of glucose abnormalities.
•Ability and willingness to give written informed consent and to comply with the requirements of the study.
•Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines.

•Current treatment with a TZD or fibrate
•Prior intolerance to a TZD or fibrate
•Previous participation in a trial with aleglitazar
•Other types of diabetes
•Inadequate liver, hematologic or renal function as defined by protocol
•Symptomatic congestive heart failure classified as NYHA class II-IV
•Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding the randomization
•Peripheral edema which in the judgment of the investigator is believed to be clinically 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 cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
•Women with a positive pregnancy test, breast feeding or of childbearing potential not using medically approved, highly effective methods of contraception
•Participation in any clinical trial.

发起方