Estudio de fase 3B para evaluar el potencial de aleglitazar en la reducción del riesgo cardiovascular en pacientes con enfermedad cardiovascular estable y anomalías glucémicas

CompletadoFase 3ClinicalTrials.gov

ID: NCT01715818Tipo: INTERVENTIONALInicio: 1 de dic de 2012Fin estimado: 1 de nov de 2013

Resumen

Este estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y multicéntrico evaluará el potencial de aleglitazar para reducir el riesgo cardiovascular en pacientes con enfermedad cardiovascular estable y anomalías glucémicas. Los pacientes serán aleatorizados 1:1 para recibir aleglitazar 150 mcg por vía oral una vez al día o placebo equivalente.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age \>/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset \>/= 3 months prior to randomization and stable in the Investigator's judgment B. Age \>/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
Patients with glucose abnormalities based on one of the following A-B criteria:
A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities
Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Criterios de exclusión

Current treatment with a thiazolidinedione (TDZ) or fibrate
Prior intolerance to a TDZ or fibrate
Previous participation in a trial with aleglitazar
Other types of diabetes
Inadequate liver, hematologic or renal function
Symptomatic heart failure classified as NYHA class II-IV
Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
Currently scheduled for arterial revascularization procedures
Systemic corticosteroid therapy for \> 2 weeks within 3 months prior to screening
Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

Intervenciones

drug

Placebo

matching aleglitazar placebo tablet orally daily

drug

aleglitazar

150 mcg orally daily

Ubicaciones

Caba, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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