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

Use our guide to learn which trials are right for you!

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.


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
?
mi
from
Zanesville, OH
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Beaver, PA
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
?
mi
from
Burke, VA
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Clinton, SC
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
?
mi
from
Cudahy, CA
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Dunwoody, GA
Click here to add this to my saved trials
?
mi
from
Eagle, ID
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Elizabeth City, North Carolina 27909
?
mi
from
Elizabeth City, NC
Click here to add this to my saved trials
?
mi
from
Encino, CA
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
2720 Rivers Road
Fall Rivers, Mississippi 02720
?
mi
from
Fall Rivers, MS
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fleetwood, PA
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fremont, NE
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Gallipolis, OH
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Harleysville, PA
Click here to add this to my saved trials
?
mi
from
Haverhill, MA
Click here to add this to my saved trials
?
mi
from
Hawaiian Gardens, CA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jersey Shore, Pennsylvania 17740
?
mi
from
Jersey Shore, PA
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
?
mi
from
Kingwood, TX
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Lomita, CA
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Manassas, VA
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
Melrose Park, IL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Morganton, NC
Click here to add this to my saved trials
?
mi
from
Murray, UT
Click here to add this to my saved trials
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
North Massapequa, New York 11758
?
mi
from
North Massapequa, NY
Click here to add this to my saved trials
North Richland Hills, Texas 76180
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Oxon Hill, MD
Click here to add this to my saved trials
?
mi
from
Panama City, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
?
mi
from
Port Orchard, WA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials