A study of Aleglitazar in Patients with Stable Cardiovascular disease and Glucose Abnormalities

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10036481Term: Pre-diabetesSystem Organ Class: 100000004861; Stable Cardiovascular Disease and Diabetes Mellitus Type 2 or Pre-diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000671-16-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-26
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 19000

Inclusion Criteria

• Adult patients, >/= 40 years of age • Prior Cardiovascular event, Coronary, Cerebrovascular or Perhipheral Arterial Disease • Established Diabetes Mellitus Type 2 or Hba1c>/=5.7%
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6300

Exclusion Criteria

• Concomitant treatment with a thiazolidinedione and/or fibrate • Triglycerides >500 mg/dL • Anaemia • Estimated glomerular filtration rate <30mL/min/1.73m2 • Symptomatic congestive heart failure classified as NYHA class II-IV • Hospitalisation for congestive heart failure in last year

Study & Design

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