Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

Phase 1

• Conditions: Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event; MedDRA version: 12.0Level: LLTClassification code 10007649Term: Cardiovascular disorder

• Registration Number: EUCTR2009-012269-71-FR
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-11
• Study Completion: 2013-11-18
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7226

Inclusion Criteria

- Adults >18 years of age

- Type 2 diabetes mellitus

- Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- eGFR <45 ml/in/1.73 m2
- Concomitant treatment with a thiazolidinedione and/or fibrate
- Triglycerides >400 mg/dL
- Anaemia
- Symptomatic congestive heart failure classified as NYHA class II-IV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified