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

A Phase 3b Study To Evaluate The Potential Of Aleglitazar To Reduce Cardiovascular Risk In Patients With Stable Cardiovascular Disease And Glucose Abnormalities - AlePrevent

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000671-16-SE

Enrollment

19000

Registered

2012-09-06

Start date

2012-11-04

Completion date

Unknown

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Aleglitazar Product Code: RO0728804/F23 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Aleglitazar CAS Number: 475479-34-6 Current Sponsor code: RO0728804 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Exclusion criteria: • Concomitant treatment with a thiazolidinedione and/or fibrate • Triglycerides >500 mg/dL • Anaemia • Estimated glomerular filtration rate <45 mL/min/1.73m2 • Symptomatic congestive heart failure classified as NYHA class II-IV • Hospitalisation for congestive heart failure in last year

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the addition of aleglitazar versus placebo will reduce a composite outcome of CV death, non-fatal myocardial infarction or non-fatal stroke in patients with stable CVD and glucose abnormalities.;Secondary Objective: To further explore the potential of aleglitazar to reduce CV morbidity, all-cause mortality and to delay the onset of T2D.;Primary end point(s): Time to first occurrence of any component of the composite cardiovascular event of CV death, non-fatal MI ad non-fatal stroke;Timepoint(s) of evaluation of this end point: Approximately 6 years	—

Measure

Time frame

Main Objective: To determine whether the addition of aleglitazar versus placebo will reduce a composite outcome of CV death, non-fatal myocardial infarction or non-fatal stroke in patients with stable CVD and glucose abnormalities.;Secondary Objective: To further explore the potential of aleglitazar to reduce CV morbidity, all-cause mortality and to delay the onset of T2D.;Primary end point(s): Time to first occurrence of any component of the composite cardiovascular event of CV death, non-fatal MI ad non-fatal stroke;Timepoint(s) of evaluation of this end point: Approximately 6 years

—

Secondary

Measure	Time frame
Secondary end point(s): Time to first occurrence of any component of the composite all-cause mortality, non-fatal MI ad non-fatal stroke;Timepoint(s) of evaluation of this end point: Approximately 6 years	—

Countries

Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Indonesia, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results