A Double Blind, Randomized, Placebo Controlled, Multicenter, Dose Finding Study of Oral AEB071 Assessing Psoriasis Area and Severity Index (PASI) Response and a Function of Dose and Treatment Duration (Primary Outcome) in Patients With Plaque Psoriasis

CompletadoFase 2ClinicalTrials.gov

ID: NCT00885196Tipo: INTERVENTIONALInicio: 1 de abr de 2009

Traducción no disponible, mostrando original

Resumen

This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
Severity of disease meeting all of the following three criteria:
PASI score of 10 or greater
Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
Investigator's Global Assessment (IGA) score of 3 or greater

Criterios de exclusión

Hematological abnormalities
Heart rate \< 50 or \> 90 bpm when resting for 5 minutes
Family history of long QT syndrome
History of tachyarrhythmia
History of conduction abnormality i.e., PR \> 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
Known history of congestive heart failure
History of percutaneous coronary intervention (PCI) or cardiac ablation
History of stroke or transient ischemic attack (TIA)
Implanted cardiac pacemaker or defibrillator
History of malignancy of any organ system
Current guttate, generalized erythrodermic, or pustular psoriasis
Current drug associated psoriasis

Intervenciones

drug

Placebo

drug

AEB071

Ubicaciones

Novartis Investigative site

Buenos Aires, Argentina

Novartis Investigative site

Mendoza, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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