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

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 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Tyrosine Imatinib Imatinib mesylate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2006
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 STI571	Drug: Imatinib mesylate Other Name: Imatinib, Glivec, Gleevec
Placebo Comparator: 2 Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Novartis Investigative site
Hannover, Germany
United Kingdom
Novartis Investigative site
Glasgow, United Kingdom
Novartis Investigative site
Papworth, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Investigative site

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ghofrani HA, Morrell NW, Hoeper MM, Olschewski H, Peacock AJ, Barst RJ, Shapiro S, Golpon H, Toshner M, Grimminger F, Pascoe S. Imatinib in pulmonary arterial hypertension patients with inadequate response to established therapy. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1171-7. Epub 2010 Jun 25.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00477269 History of Changes
Other Study ID Numbers:	CSTI571E2203
Study First Received:	May 22, 2007
Last Updated:	October 17, 2011
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

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Imatinib

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013