Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension Imatinib 6MWD Borg scale Pulmonary hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

Detailed description:

Arms:
arm 1: Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. arm 2: Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.

Interventions: intervention 1: imatinib mesylate intervention 2: Placebo
Intervention descriptions: intervention 1: Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily. intervention 2: Placebo to imatinib 100 mg film coated tablets

Protocol document: