A Study With Aleglitazar in Patients With a Recent Acute CoronarySyndrome and Type 2 Diabetes Mellitus
- Conditions
- Type 2 diabetes patients with a recent acute coronary syndrome (ACS) eventMedDRA version: 14.1Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-012269-71-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7000
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: Symptomatic congestive heart failure classified as NYHA class I-IV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method