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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease, Diabetes Mellitus Type 2 Drug: Placebo Drug: aleglitazar Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aleglitazar Drug: aleglitazar
150 mcg orally daily
Placebo Comparator: Placebo Drug: Placebo
matching aleglitazar placebo tablet orally daily

Outcome Measures

Primary Outcome Measures :
  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) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715818

  Show 393 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01715818     History of Changes
Other Study ID Numbers: BC28027
2012-000671-16 ( EudraCT Number )
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases