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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00477269
First received: May 22, 2007
Last updated: October 17, 2013
Last verified: October 2013
  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:


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
Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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, 2013
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 July 22, 2014