Trial record 4 of 5 for:    QTI571

Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392495
First received: July 11, 2011
Last updated: November 7, 2013
Last verified: November 2013

July 11, 2011
November 7, 2013
June 2011
May 2014   (final data collection date for primary outcome measure)
Number of patients with adverse events as a measure of the safety and tolerability of QTI571 [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01392495 on ClinicalTrials.gov Archive Site
  • Measure: Changes in six minute walk distance (6MWD) from baseline [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Measure: Time to clinical worsening endpoints [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension
An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension

This study is an extension to study CQTI571A2102 and will evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Imatinib
Experimental: QTI571
Intervention: Drug: Imatinib
Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galié N, Gómez-Sánchez MA, Grimminger F, Grünig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct

Exclusion Criteria:

  • Patients with left ventricular ejection fraction (LVEF) < 45%
  • Patients with thrombocytopenia, platelet count < 50 x109/L (50 x 103/µL).
  • Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160 mmHg or diastolic pressure > 90 mmHg.
  • Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block.

Other protocol-defined inclusion/exclusion criteria may apply

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Germany,   Italy,   Lithuania,   United Kingdom
 
NCT01392495
CQTI571A2102E1, 2010-021960-14
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2013

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