A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Women's Studies, Diabetes |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Reproductive |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 8/3/2016 |
Start Date: | December 2012 |
End Date: | November 2013 |
A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
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.
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.
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
We found this trial at
130
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials