Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

• Status: Completed
• Trial end date: 2012-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bosentan; Imatinib Mesylate; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Participants with Pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Diagnostic Group 1, with pulmonary vascular resistance > 800 dyne*sec*cm^-5,

• On stable doses of bosentan and sildenafil

Exclusion Criteria:

• Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as congenital large or small unrepaired systemic to pulmonary shunts, portal hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies, myeloproliferative disorders, veno-occlusive pulmonary disease

• Significant lung diseases not related to PAH

• Significant cardiovascular system disorders, hematological system disorders, liver insufficiency

• Significant diseases in other organ system.

Other protocol-defined inclusion/exclusion criteria may apply