A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease, Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT01715818

Run by

Hoffmann-La Roche

People needed

1999

Starts

2012-12-01

Expected to finish

2013-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Gilbert, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Cudahy, California, United States
• Study site — Encino, California, United States
• Study site — Fresno, California, United States
• Study site — Fresno, California, United States
• Study site — Hawaiian Gardens, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Lomita, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — North Hollywood, California, United States
• Study site — Northridge, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Stockton, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Torrance, California, United States
• Study site — Tustin, California, United States
• Study site — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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