Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00477269

Purpose

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

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Imatinib mesylate Drug: Placebo	Phase II Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Imatinib Imatinib mesylate Tyrosine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)

Further study details as provided by Novartis:

Primary Outcome Measures:

-Safety and tolerability as assessed by. blood pressure, heart rate, ECG, hematology, biochemistry, urinalysis, echocardiography, adverse events and serious adverse events. -Efficacy as measured by an improvement in 6-minute walk test at monthly inter [ Time Frame: 6 months ]

Secondary Outcome Measures:

- Improvement in clinical status (assessment of WHO class & Borg Score) - Changes in pulmonary hemodynamic parameters - Time to clinical worsening - Changes in plasma biomarker levels [ Time Frame: 6 months ]

Estimated Enrollment:	60
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental STI571	Drug: Imatinib mesylate
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477269

Locations

United States, California
Novartis Investigative site
Los Angeles, California, United States, 90073
United States, New Jersey
Novartis investigative site
Newark, New Jersey, United States, 07112
United States, New York
Novartis Investigative site
New York, New York, United States, 10032
Austria
Novartis Investigative site
Graz, Austria
Germany
Novartis Investigative site
Giessen, Germany
United Kingdom
Novartis Investigative site
Papworth, United Kingdom
Novartis Investigative site
Glasgow, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Investigative site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSTI571E2203
Study First Received:	May 22, 2007
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00477269
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Austria: Agency for Health and Food Safety; United States: Food and Drug Administration

Keywords provided by Novartis:

Pulmonary Arterial Hypertension, tyrosine kinase inhibitor, STI571

Study placed in the following topic categories:

Imatinib
Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Cardiovascular Diseases
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009