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A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715818
First received: October 25, 2012
Last updated: September 1, 2016
Last verified: September 2016
History of Changes

October 25, 2012
September 1, 2016
December 2012
November 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01715818 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cardiovascular Disease, Diabetes Mellitus Type 2
  • Drug: Placebo
    matching aleglitazar placebo tablet orally daily
  • Drug: aleglitazar
    150 mcg orally daily
  • Experimental: Aleglitazar
    Intervention: Drug: aleglitazar
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1999
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
Brazil,   China,   Finland,   France,   India,   Indonesia,   Peru,   Philippines,   Ukraine
 
NCT01715818
BC28027, 2012-000671-16
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

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