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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01042769

First received: January 5, 2010

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2010

Last Updated Date

May 13, 2013

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01042769 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Aleglitazar
aleglitazar 150 micrograms po daily
Drug: Placebo
placebo control po daily

Study Arm (s)

Experimental: 1
Intervention: Drug: Aleglitazar
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

7244

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 <45mL/min/1.73m2
Concomitant treatment with a thiazolidinedione and/or fibrate
Triglycerides >400 mg/dL
Anaemia
Symptomatic congestive heart failure classified as NYHA class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Sweden, Thailand, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01042769

Other Study ID Numbers ^ICMJE

BC22140, 2009-012269-71

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

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

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