drugset / Trial / NCT01117987

Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

NCT01117987 ↗

Phase 3 Terminated 144 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

Timeline

Start
2010-04
Primary completion
2014-04
Completion
2014-04

Outcome

Outcome not reported

Stopped: “Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 200 mg Oral
Subject Imatinib Small molecule 400 mg Oral