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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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

Key facts

Study ID

NCT00477269

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2006-04-01

Expected to finish

2014-01-01

Last updated by the study team

2015-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis investigative site — Newark, New Jersey, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Graz, Austria, Austria
• Novartis Investigative site — Graz, Austria
• Novartis Investigative Site — Hanover, Germany, Germany
• Novartis Investigative Site — Giessen, Germany
• Novartis Investigative site — Giessen, Germany
• Novartis Investigative site — Hanover, Germany
• Novartis Investigative Site — Cambridge, Cambridgeshire, United Kingdom
• Novartis Investigative Site — Glasgow, United Kingdom
• Novartis Investigative site — Glasgow, United Kingdom
• Novartis Investigative site — Papworth Everard, United Kingdom

Full record on ClinicalTrials.gov

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