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

Phase 1

• Conditions: Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event; MedDRA version: 15.1 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-012269-71-GB
• 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: 2010-03-15
• Study Completion: 2013-11-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 4700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2300

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: Congestive heart failure classified as NYHA class I-IV)

Study & Design

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