Aleglitazar and cardiovascular risk (AlePrevent)

• Research type

  Research Study

• Full title

  A Phase 3b Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients with Stable Cardiovascular Disease and Glucose Abnormalities

• IRAS ID

  114652

• Contact name

  Naveed Sattar

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2012-000671-16

• Research summary

  Cardiovascular disease remains the leading cause of mortality worldwide. Abnormalities in blood lipids and glucose, including those seen in type 2 diabetes, are believed to contribute to the development and progression of this disease. Aleglitazar is a dual peroxisome proliferator activated receptor alpha and gamma (PPAR a/?) agonist. Hence, it provides control of both glucose and lipid metabolism.The aim of this international trial is to see if a once daily oral dose of 150 æg aleglitazar reduces the incidence of cardiovascular and other serious complications in adult patients with stable cardiovascular disease and blood glucose abnormalities, when compared to treatment with placebo. The safety and tolerability of aleglitazar will also be assessed.Approximately 19,000 adult male and female patients with stable cardiovascular disease, type 2 diabetes, or elevated glycosylated haemoglobin A1c levels will be allocated randomly (like flipping a coin) to receive either aleglitazar or placebo.Patients will be assessed 1, 3 and 6 months after starting study treatment, and then at 6 monthly intervals until the end of trial. It is anticipated that the duration of the trial for each patient will be between 3 to 5 years.The study assessments will include:- Physical examinations- Measurement of blood pressure, heart rate, weight, and waist and hip circumference- ECGs (heart traces)- Blood and urine sample collection for laboratory safety and efficacy testingThe study will end when sufficient patients experience pre-specified cardiovascular endpoint events and all patients have been followed for at least 3 years unless they are prematurely discontinued from the study.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  12/ES/0086

• Date of REC Opinion

  6 Feb 2013

• REC opinion

  Further Information Favourable Opinion