A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES
2 other identifiers
interventional
1,999
25 countries
357
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2012
Shorter than P25 for phase_3
357 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 2, 2016
November 1, 2016
11 months
October 25, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)
5 years
Secondary Outcomes (2)
Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
5 years
Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
5 years
Study Arms (2)
Aleglitazar
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (392)
Unknown Facility
Muscle Shoals, Alabama, 35662, United States
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Gilbert, Arizona, 85295, United States
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Phoenix, Arizona, 85018, United States
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Tucson, Arizona, 85724, United States
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Cudahy, California, 90201, United States
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Encino, California, 91436, United States
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Fresno, California, 93720, United States
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Fresno, California, 93721, United States
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Hawaiian Gardens, California, 90716, United States
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Huntington Beach, California, 92646, United States
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Lomita, California, 90717, United States
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Long Beach, California, 90807, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90036, United States
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Los Angeles, California, 90057, United States
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Los Gatos, California, 95032, United States
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North Hollywood, California, 91606, United States
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Northridge, California, 91325, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95821, United States
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San Diego, California, 92103, United States
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Stockton, California, 95207, United States
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Thousand Oaks, California, 91360, United States
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Torrance, California, 90502, United States
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Tustin, California, 92780, United States
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Ventura, California, 90265, United States
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Denver, Colorado, 80209, United States
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Atlantis, Florida, 33462, United States
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Bradenton, Florida, 34208, United States
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Brooksville, Florida, 34601, United States
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Clearwater, Florida, 33755, United States
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Clearwater, Florida, 33756, United States
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DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33316, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33144, United States
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Miami Beach, Florida, 33140, United States
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New Port Richey, Florida, 34652, United States
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Orlando, Florida, 32822, United States
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Panama City, Florida, 32401, United States
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Pinellas Park, Florida, 33781, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33613, United States
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West Palm Beach, Florida, 33401, United States
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Winter Park, Florida, 32789, United States
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Augusta, Georgia, 30909, United States
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Decatur, Georgia, 30030, United States
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Dunwoody, Georgia, 30338, United States
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Eagle, Idaho, 83616, United States
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Idaho Falls, Idaho, 83404, United States
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Melrose Park, Illinois, 60160, United States
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Brownsburg, Indiana, 46112, United States
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Evansville, Indiana, 47714, United States
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Valparaiso, Indiana, 46383, United States
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Council Bluffs, Iowa, 51501, United States
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Iowa City, Iowa, 52242, United States
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Wichita, Kansas, 67203, United States
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Lexington, Kentucky, 40504, United States
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Louisville, Kentucky, 40213, United States
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Owensboro, Kentucky, 42303, United States
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Alexandria, Louisiana, 71301, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21209, United States
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Baltimore, Maryland, 21215, United States
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Oxon Hill, Maryland, 20745, United States
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Haverhill, Massachusetts, 01830, United States
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Traverse City, Michigan, 49684, United States
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Fall Rivers, Mississippi, 02720, United States
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Kansas City, Missouri, 64111, United States
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Bellevue, Nebraska, 68005, United States
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Fremont, Nebraska, 68025, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89121, United States
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Las Vegas, Nevada, 89123, United States
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Elizabeth, New Jersey, 07202, United States
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Albany, New York, 12206-1098, United States
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North Massapequa, New York, 11758, United States
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Smithtown, New York, 11787, United States
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Syracuse, New York, 13202, United States
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Westfield, New York, 14787, United States
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Elizabeth City, North Carolina, 27909, United States
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Morganton, North Carolina, 28655, United States
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Raleigh, North Carolina, 27609, United States
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Shelby, North Carolina, 28150, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Akron, Ohio, 44313, United States
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Gallipolis, Ohio, 45631, United States
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Kettering, Ohio, 45429, United States
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Zanesville, Ohio, 43701, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97220, United States
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Beaver, Pennsylvania, 15009, United States
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Doylestown, Pennsylvania, 18901, United States
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Fleetwood, Pennsylvania, 19522, United States
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Harleysville, Pennsylvania, 19438, United States
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Jersey Shore, Pennsylvania, 17740, United States
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Lansdale, Pennsylvania, 19446, United States
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Philadelphia, Pennsylvania, 19114, United States
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Pittsburgh, Pennsylvania, 15202, United States
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Sellersville, Pennsylvania, 18960, United States
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Uniontown, Pennsylvania, 15401, United States
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Clinton, South Carolina, 29325, United States
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Greer, South Carolina, 29651, United States
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Murrells Inlet, South Carolina, 29576, United States
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Varnville, South Carolina, 29944, United States
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Dakota Dunes, South Dakota, 57049, United States
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Chattanooga, Tennessee, 37404-3230, United States
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Chattanooga, Tennessee, 37411, United States
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Jackson, Tennessee, 38305, United States
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Knoxville, Tennessee, 27912, United States
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Nashville, Tennessee, 37203, United States
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Arlington, Texas, 76012, United States
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Corpus Christi, Texas, 78404, United States
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Dallas, Texas, 75230, United States
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El Paso, Texas, 79925, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77036, United States
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Houston, Texas, 77074, United States
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Kingwood, Texas, 77339, United States
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McAllen, Texas, 78501, United States
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New Braunfels, Texas, 78130, United States
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North Richland Hills, Texas, 76180, United States
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San Antonio, Texas, 78224, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75701, United States
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Bountiful, Utah, 84010, United States
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Draper, Utah, 84020, United States
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Murray, Utah, 84123, United States
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Salt Lake City, Utah, 84124, United States
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Burke, Virginia, 22015, United States
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Manassas, Virginia, 20110, United States
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Suffolk, Virginia, 23435, United States
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Port Orchard, Washington, 98366, United States
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Spokane, Washington, 99207, United States
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Madison, Wisconsin, 53719, United States
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Caba, C1119ACN, Argentina
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Caba, C1428DCO, Argentina
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Camperdown, New South Wales, 2050, Australia
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Gosford, New South Wales, 2250, Australia
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Kogarah, New South Wales, 2217, Australia
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Wollongong, New South Wales, 2500, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, 5000, Australia
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Woodville, South Australia, 5011, Australia
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Launceston, Tasmania, 7250, Australia
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Geelong, Victoria, 3220, Australia
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Heidelberg, Victoria, 3081, Australia
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Melbourne, Victoria, 3004, Australia
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Armadale, Western Australia, 6112, Australia
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Perth, Western Australia, 6009, Australia
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Braunau am Inn, 5280, Austria
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Feldkirch, 6800, Austria
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Graz, 8036, Austria
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Vienna, 1130, Austria
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Kelowna, British Columbia, V1Y 1E4, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Bathurst, New Brunswick, E2A 4X7, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Collingwood, Ontario, L9Y 1W3, Canada
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Greater Sudbury, Ontario, P3C 5K7, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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London, Ontario, N5W 6A2, Canada
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London, Ontario, N6G 0J4, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Newmarket, Ontario, L3Y 8C3, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Quebec, Prince Edward Island, G1V 4G2, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Chicoutimi, Quebec, G7H 7Y8, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Lachine, Quebec, H8S 2E4, Canada
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Laval, Quebec, H7M 3L9, Canada
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Longueuil, Quebec, J4M 2X1, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H1T 3Y7, Canada
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Montreal, Quebec, H2P 2M1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Québec, Quebec, G3K 2P8, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Saint-Lambert, Quebec, J4P 2H4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Ste-Foy, Quebec, G1W 4R4, Canada
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Terrebonne, Quebec, J6V 1S8, Canada
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Saskatoon, Saskatchewan, S7K 3H3, Canada
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Las Condes, 7500710, Chile
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Santiago, 7500010, Chile
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Santiago, 7500347, Chile
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Santiago, 7500710, Chile
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Temuco, 4781156, Chile
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Temuco, 4790869, Chile
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Temuco, 4813299, Chile
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Barranquila, Colombia
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Barranquilla, Colombia
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Bogotá, Colombia
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Cartagena, Colombia
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Floridablanca, Colombia
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Medellín, Colombia
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Beroun, 266 01, Czechia
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Brno, 601 77, Czechia
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Brno, 625 00, Czechia
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Jihlava, 586 33, Czechia
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Liberec, 460 63, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Prague, 140 21, Czechia
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Prague, 140 59, Czechia
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Prague, 149 00, Czechia
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Prague, 150 06, Czechia
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Prague, 150 30, Czechia
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Prague, 158 00, Czechia
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Praha 4 - Krc, 140 59, Czechia
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Slaný, 274 51, Czechia
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Třebíč, 674 01, Czechia
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Narva, 20307, Estonia
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Tallinn, 10138, Estonia
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Tartu, 50410, Estonia
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Tartu, 51014, Estonia
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Berlin, 10117, Germany
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Berlin, 13125, Germany
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Bochum, 44787, Germany
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Charlottenburg, 14050, Germany
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Chemnitz, 09111, Germany
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Cologne, 50937, Germany
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Damme, 49401, Germany
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Dresden, 01067, Germany
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Frankfurt, 60596, Germany
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Frankfurt, 65929, Germany
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Hanover, 30159, Germany
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Homburg/Saar, 66421, Germany
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Kassel, 34121, Germany
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Köthen, 06366, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39104, Germany
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Mönchengladbach, 41063, Germany
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Münster, 48145, Germany
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Neunkirchen, 66539, Germany
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Wangen, 88239, Germany
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Balatonfüred, 8230, Hungary
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Budapest, 1023, Hungary
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Budapest, 1027, Hungary
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Budapest, 1036, Hungary
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Budapest, 1085, Hungary
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Budapest, 1097, Hungary
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Budapest, 1125, Hungary
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Budapest, 1131, Hungary
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Debrecen, 4032, Hungary
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Gyöngyös, 3200, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Nyíregyháza, 4400, Hungary
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Pápa, 8500, Hungary
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Szeged, 6720, Hungary
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Székesfehérvár, 8000, Hungary
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Szolnok, 5004, Hungary
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Zalaegerszeg, 8900, Hungary
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Giv‘atayim, 53583, Israel
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Naples, Campania, 80122, Italy
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40133, Italy
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Rome, Lazio, 00128, Italy
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Rome, Lazio, 00185, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20138, Italy
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Pavia, Lombardy, 27100, Italy
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Catania, Sicily, 95122, Italy
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Palermo, Sicily, 90127, Italy
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Pesaro, The Marches, 61121, Italy
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Massa, Tuscany, 54100, Italy
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Tochigi, 329-0498, Japan
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Liepāja, 3400, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1012, Latvia
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Riga, LV-1024, Latvia
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Riga, LV-1058, Latvia
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Kaunas, 48259, Lithuania
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Kaunas, 50184, Lithuania
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Kaunas, LT-47144, Lithuania
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Vilnius, LT-02169, Lithuania
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Johor Bahru, 80100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 68100, Malaysia
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Perak, 34000, Malaysia
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Sabak Bernam, 88300, Malaysia
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Sarawak, 94300, Malaysia
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Aguascalientes, 20234, Mexico
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México, 03300, Mexico
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Monclova, 25750, Mexico
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Monterrey, 64460, Mexico
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Xalapa, 91020, Mexico
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Bialystok, 15-276, Poland
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Gdynia, 81-384, Poland
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Gdynia, 81-472, Poland
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Katowice, 40-748, Poland
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Katowice, 40-954, Poland
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Krakow, 30-015, Poland
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Krakow, 30-082, Poland
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Krakow, 31-202, Poland
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Krakow, 31-261, Poland
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Lodz, 90-242, Poland
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Lublin, 20-044, Poland
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Lublin, 20-093, Poland
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Nowy Sącz, 33-300, Poland
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Opole, 45-367, Poland
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Rzeszów, 35-055, Poland
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Warsaw, 01-192, Poland
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Wroclaw, 50-088, Poland
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Baia Mare, 430123, Romania
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Bucharest, 010507, Romania
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Bucharest, 010825, Romania
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Bucharest, 020359, Romania
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Bucharest, 050098, Romania
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Bucharest, 061119, Romania
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Bucharest, 800578, Romania
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Craiova, 200642, Romania
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Oradea, 410169, Romania
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Ploieşti, 100163, Romania
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Târgu Mureş, 540124, Romania
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Kemerovo, Russia
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Saint Petersburg, 199034, Russia
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Tomsk, 634012, Russia
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Pretoria, 0103, South Africa
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Pretoria West, 0183, South Africa
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Busan, 602-715, South Korea
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Busan, 602-739, South Korea
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Daejeon, 35015, South Korea
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Gwangju, 61469, South Korea
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Gyeonggi-do, 10380, South Korea
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Gyeonggi-do, 11765, South Korea
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Gyeonggi-do, 410-773, South Korea
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Gyeonggi-do, 431-070, South Korea
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Gyeonggi-do, 443-380, South Korea
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Incheon, 405-760, South Korea
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Seoul, 05030, South Korea
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Seoul, 06273, South Korea
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Seoul, 130-872, South Korea
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Seoul, 137-701, South Korea
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Seoul, 156-707, South Korea
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Suwon, 442-723, South Korea
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Wŏnju, 220-701, South Korea
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Albacete, Albacete, 02006, Spain
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Sant Joan d'Alacant, Alicante, 3550, Spain
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Almería, Almeria, 04009, Spain
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Palma de Mallorca, Balearic Islands, 07014, Spain
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Girona, Girona, 17007, Spain
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Granada, Granada, 18012, Spain
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Huelva, Huelva, 21005, Spain
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Santiago de Compostela, La Coruña, 15706, Spain
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Lleida, Lerida, 25198, Spain
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Madrid, Madrid, 41013, Spain
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Málaga, Malaga, 29006, Spain
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Málaga, Malaga, 29009, Spain
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Málaga, Malaga, 29010, Spain
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Seville, Sevilla, 41009, Spain
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Tarragona, Tarragona, 43007, Spain
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Alzira, Valencia, 46600, Spain
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Valencia, Valencia, 46014, Spain
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Malmo, 205 02, Sweden
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Stockholm, 111 35, Sweden
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Stockholm, 113 61, Sweden
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Stockholm, 171 76, Sweden
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Bangkok, 10330, Thailand
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Khon Kaen, 40002, Thailand
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Birmingham, B15 2SQ, United Kingdom
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Cardiff, CF14 5GJ, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Edinburgh, EH16 4TJ, United Kingdom
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Glasgow, G12 8QQ, United Kingdom
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Glasgow, G20 0SP, United Kingdom
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Inverness, IV2 4AG, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Liverpool, L9 7AL, United Kingdom
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Manchester, M15 6SX, United Kingdom
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Mortimer, RG7 3SQ, United Kingdom
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Reading, RG2 0TG, United Kingdom
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Soham, Ely, CB7 5JD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 29, 2012
Study Start
December 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11