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

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Imatinib mesylate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00477269

2005-005569-12

CSTI571E2203

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to World Conference on Pulmonary Hypertension classification (Venice, 2003).
• Symptoms with a WHO class of II-IV

Exclusion criteria

• Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study
• Chronic inhaled nitric oxide therapy from start to study completion
• Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine),
• Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm.
• Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension
• Acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease
• Severe (systemic) arterial hypertension (> 200 mmHg (systolic) or > 120 mmHg (diastolic)) Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

STI571

Experimental group

Description:

STI571

Treatment:

Drug: Imatinib mesylate

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

All Patients

Experimental group

Description:

Open label extension

Treatment:

Drug: Imatinib mesylate