A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:February 2010
End Date:November 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

This double-blind, parallel, two-arm study will evaluate the potential to reduce
cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared
to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and
type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or
placebo once daily as oral doses. The study will last until at least 950 events occur, but
time on study treatment will be for at least 2.5 years.


Inclusion Criteria:

- Adults >18 years of age

- Type 2 diabetes mellitus

- Hospitalization for ACS event and randomization between hospital discharge and 8
weeks after the ACS index event (day of hospitalization)

Exclusion Criteria:

- Estimated glomerular filtration rate <45 mL/min/1.73m2

- Concomitant treatment with a thiazolidinedione and/or fibrate

- Triglycerides >400 mg/dL

- Anaemia

- Symptomatic congestive heart failure classified as New York Heart Association (NYHA)
class II-IV (France and Germany: Symptomatic congestive heart failure classified as
NYHA class I-IV)
We found this trial at
185
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Clinical Trial Facility in Huntington West Virginia
Huntington, West Virginia 25701
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Albany, New York 12205
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Albuquerque, New Mexico
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Alexandria, Louisiana 71301
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Alpena, Michigan 49707
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Amarillo, Texas
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Ames, Iowa 50010
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Anaheim, California 92801
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Ann Arbor, Michigan 48109
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Clinical Trial Facility in Annapolis Maryland
Annapolis, Maryland 21401
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Clinical Trial Facility in Aventura Florida
Aventura, Florida 33108
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Clinical Trial Facility in Bangor Maine
Bangor, Maine 04402
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Clinical Trial Facility in Banning California
Banning, California 92220
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Clinical Trial Facility in Bay City Michigan
Bay City, Michigan 48708
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Clinical Trial Facility in Bellaire Texas
Bellaire, Texas 77402
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Clinical Trial Facility in Beloit Wisconsin
Beloit, Wisconsin
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Birmingham, Alabama
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Boston, Massachusetts
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Boynton Beach, Florida 33472
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Clinical Trial Facility in Bridgeport Connecticut
Bridgeport, Connecticut
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Bridgewater, New Jersey 08807
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Bronx, New York
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Brooklyn, New York 11215
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Buenos Aires,
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Buffalo, New York
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Burlington, Wisconsin 53105
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Canton, Ohio 44718
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Carmichael, California 95608
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Chambersburg, Pennsylvania 17201
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Charlotte, North Carolina 28207
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Chesterfield, Missouri
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Cincinnati, Ohio
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Clearwater, Florida 33756
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Cleveland, Ohio
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Colorado Springs, Colorado 80910
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Columbia, Maryland 21044
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Columbus, Ohio 43214
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Convington, Louisiana 70433
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Coral Springs, Florida 33065
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Council Bluffs, Iowa 51501
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Dallas, Texas 75390
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Danville, Pennsylvania
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Danville, Virginia 24541
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Davenport, Iowa 52803
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Dayton, Ohio 45409
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Decatur, Georgia 30033
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Doral, Florida 33166
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Durham, North Carolina
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Edgewater, Florida
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Elizabeth, Florida 07202
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Elizabethtown, Kentucky 42701
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Elkhart, Indiana 46514
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Fall River, Massachusetts 02720
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Clinical Trial Facility in Flint Michigan
Flint, Michigan 48532
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Freemont, Nebraska 68025
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Fresno, California 93706
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Ft. Lauderdale, Florida 33308
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Fullerton, California 92835
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Gainesville, Florida 32610
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Glendale, California 91206
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Grapevine, Texas
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Clinical Trial Facility in Great Falls Montana
Great Falls, Montana 59405
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Clinical Trial Facility in Green Bay Wisconsin
Green Bay, Wisconsin 54301
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Clinical Trial Facility in Greenville North Carolina
Greenville, North Carolina 27834
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Greer, South Carolina 29650
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Gurnee, Illinois 60031
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Hammond, Louisiana 70403
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Harrisburg, Pennsylvania 17110
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Hartford, Connecticut 06106
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Hollywood, Florida 33021
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Houma, Louisiana
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Houston, Texas
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Hyannis, Massachusetts 02601
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Indianapolis, Indiana 46202
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Inglewood, California 90301
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Jackson, Mississippi 39216
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Jacksonville Beach, Florida 32250
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Johnson City, Tennessee 37604
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Clinical Trial Facility in Kalamazoo Michigan
Kalamazoo, Michigan 49048
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Clinical Trial Facility in Kerrville Texas
Kerrville, Texas 78028
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Kettering, Ohio 45429
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Kingsport, Tennessee 37660
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Kingwood, Texas
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Lacrosse, Wisconsin 54601
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Lafayette, Indiana 47904
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Lafayette, Louisiana 70503
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Laguna Hills, California 92653
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Lansing, Michigan 48912
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LaPlace, Louisiana 70068
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Las Vegas, Nevada 89135
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Layton, Utah 84041
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Lexington, Tennessee 38351
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Long Beach, California 90806
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Los Angeles, California
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