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

May 22, 2007
October 17, 2013
May 2006
June 2013   (final data collection date for primary outcome measure)
-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 ]
-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 ]
Complete list of historical versions of study NCT00477269 on ClinicalTrials.gov Archive Site
- 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 ]
- 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 ]
Not Provided
Not Provided
 
Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension
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)

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Imatinib mesylate
    Other Name: Imatinib, Glivec, Gleevec
  • Drug: Placebo
  • Experimental: 1
    STI571
    Intervention: Drug: Imatinib mesylate
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
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. doi: 10.1164/rccm.201001-0123OC. Epub 2010 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Germany,   United Kingdom
 
NCT00477269
CSTI571E2203
Yes
Novartis
Novartis
Not Provided
Principal Investigator: Novartis Investigative site
Novartis
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP