A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

CompletadoFase 3ClinicalTrials.gov

ID: NCT00658515Tipo: INTERVENTIONALInicio: 1 de abr de 2008Fin estimado: 1 de sept de 2012

Traducción no disponible, mostrando original

Resumen

This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

Elegibilidad

Edad mínima: 45 YearsSexo: ALL

Criterios de inclusión

adult patients, \>=45 years of age;
recently hospitalized for ACS;
clinically stable;
receiving evidence-based medical and dietary management of dyslipidemia.

Criterios de exclusión

uncontrolled diabetes;
clinically unstable;
severe anemia;
uncontrolled hypertension;
concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Intervenciones

drug

Dalcetrapib (RO4607381)

600mg po daily

drug

Evidence-based medical care for Acute Coronary Syndrome

As prescribed

drug

Placebo

po daily

Ubicaciones

Buenos Aires, Argentina

Almirante Brown, Argentina

Bahía Blanca, Argentina

Buenos Aires, Argentina

CABA, Argentina

Capital Federal, Argentina

Cipolletti, Argentina

Ciudad Autonoma Bs As, Argentina

Ciudad Autónoma de Bs. As., Argentina

Coronel Suárez, Argentina

Corrientes, Argentina

Córdoba, Argentina

Junín, Argentina

La Plata, Argentina

Mar del Plata, Argentina

Mendoza, Argentina

Quilmes, Argentina

Rosario, Argentina

Salta, Argentina

San Isidro, Argentina

San Justo, Argentina

San Martín, Argentina

San Miguel de Tucumán, Argentina

San Salvador de Jujuy, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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