Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension Nilotinib 6MWD Pulmonary Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The purpose of this trial was 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.

Detailed description:
The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months

Arms:
arm 1: Participants in cohort 1 were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants in cohort 2 were assigned to receive nilotinib 300 mg during 168 days arm 2: Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.

Interventions: intervention 1: Nilotinib intervention 2: Placebo to nilotinib
Intervention descriptions: intervention 1: Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day. intervention 2: Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day

Protocol document: