A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01042769Tipo: INTERVENTIONALInicio: 1 de feb de 2010Fin estimado: 1 de nov de 2013

Traducción no disponible, mostrando original

Resumen

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes mellitus
Adults \>18 years of age
Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Criterios de exclusión

Estimated glomerular filtration rate \<45 mL/min/1.73m2
Concomitant treatment with a thiazolidinedione and/or fibrate
Triglycerides \>400 mg/dL
Anaemia
Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

Intervenciones

drug

Aleglitazar

aleglitazar 150 micrograms po daily

drug

Placebo

placebo control po daily

Ubicaciones

Buenos Aires, Argentina

Caba, Argentina

Capital Federal, Argentina

Ciudad Autonoma Bs As, Argentina

Coronel Suárez, Argentina

Corrientes, Argentina

Córdoba, Argentina

Haedo, Argentina

Mendoza, Argentina

Morón, Argentina

Rosario, Argentina

Salta, Argentina

San Miguel de Tucumán, Argentina

Santa Fe, Argentina

Santiago del Estero, Argentina

Zárate, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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