A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
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ClinicalTrials.gov Identifier: NCT01715818 |
Recruitment Status
:
Completed
First Posted
: October 29, 2012
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date ICMJE | October 25, 2012 | |||
First Posted Date ICMJE | October 29, 2012 | |||
Last Update Posted Date | November 2, 2016 | |||
Study Start Date ICMJE | December 2012 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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) [ Time Frame: 5 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01715818 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities | |||
Official Title ICMJE | A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Cardiovascular Disease, Diabetes Mellitus Type 2 | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1999 | |||
Original Estimated Enrollment ICMJE |
19000 | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion 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
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Canada, Chile, Colombia, Czech Republic, Estonia, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Thailand, United Kingdom, United States | |||
Removed Location Countries | Brazil, China, Finland, France, India, Indonesia, Peru, Philippines, Ukraine | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01715818 | |||
Other Study ID Numbers ICMJE | BC28027 2012-000671-16 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor ICMJE | Hoffmann-La Roche | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |