Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

Phase 2/3 Completed 59 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension

Timeline

Start: 2006-04
Primary completion: 2014-01
Completion: 2014-01

Outcome

Missed primary endpoint

paper In the intention-to-treat (ITT) population there was no significant change in the 6MWD (mean ± SD) in the imatinib versus placebo group PMID 20581169 ↗

Publications

Ghofrani HA, Morrell NW, Hoeper MM, Olschewski H, Peacock AJ, Barst RJ, Shapiro S, Golpon H, Toshner M, Grimminger F, Pascoe S. Imatinib in pulmonary arterial hypertension patients with inadequate response to established therapy. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1171-7. doi: 10.1164/rccm.201001-0123OC. Epub 2010 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imatinib	Small molecule	400 mg	Oral