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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2014-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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STI571

Group Type EXPERIMENTAL

Imatinib mesylate

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

All Patients

Open label extension

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No