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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042769
First Posted: January 6, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
January 5, 2010
January 6, 2010
November 2, 2016
February 2010
November 2013   (Final data collection date for primary outcome measure)
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ]
  • Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ]
  • Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ]
Complete list of historical versions of study NCT01042769 on ClinicalTrials.gov Archive Site
  • Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ]
  • Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk [ Time Frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter ]
  • Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ]
  • Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk [ Time Frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter ]
  • Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ]
Not Provided
Not Provided
 
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Aleglitazar
    aleglitazar 150 micrograms po daily
  • Drug: Placebo
    placebo control po daily
  • Experimental: Aleglitazar
    Intervention: Drug: Aleglitazar
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7226
November 2013
November 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Grenada,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Thailand,   United Kingdom,   United States
Austria,   Bulgaria
 
NCT01042769
BC22140
2009-012269-71
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP