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Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)


A 24 Week, Randomized, Double Blind, Multicenter, Placebo-controlled Efficacy, Safety, Tolerability and Pharmacokinetics Trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)




The purpose of this trial is to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months treatment with nilotinib will significantly reduce pulmonary artery resistance.

Study Status: Recruiting


Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: 50mg Nilotinib
Drug: 150mg Nilotinib
Drug: 300mg Nilotinib
Drug: Nilotinib Placebo
Phase 2

Verified by Novartis December, 2011

Sponsored by: Novartis
Information provided by: Novartis identifier: NCT01179737

Study Type: Interventional

Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Novartis Pharmaceuticals., Study Director

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