A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00853827Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de ene de 2013

Traducción no disponible, mostrando original

Resumen

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Elegibilidad

Edad mínima: 35 YearsSexo: ALL

Criterios de inclusión

Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP \< 90mmHg.
Patients with or without current treatment for hypertension
Angiographic evidence of coronary artery disease
At least 2 qualifying Cardiovascular risk factors at Visit 1

Criterios de exclusión

Baseline IVUS determined unacceptable
Patients requiring treatment with disallowed study medications
Patients with clinically significant heart disease
Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of \< 25%
Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:
Angiotensin converting enzyme inhibitors
Angiotensin receptor blockers
aldosterone receptor blockers or a direct renin inhibitor.
Other conditions may apply

Intervenciones

drug

Placebo

drug