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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01392495
Recruitment Status : Terminated (Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
First Posted : July 12, 2011
Results First Posted : July 13, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 11, 2011
First Posted Date  ICMJE July 12, 2011
Results First Submitted Date  ICMJE March 24, 2015
Results First Posted Date  ICMJE July 13, 2015
Last Update Posted Date August 10, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
Number of Patients With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ]
Adverse event monitoring was conducted throughout the trial.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
Number of patients with adverse events as a measure of the safety and tolerability of QTI571 [ Time Frame: 96 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
  • Change From Baseline in the Six Minute Walk Distance (6MWD) [ Time Frame: baseline, 144 weeks ]
  • Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ]
  • Medical Resource Utilization [ Time Frame: 144 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
  • Measure: Changes in six minute walk distance (6MWD) from baseline [ Time Frame: 96 weeks ]
  • Measure: Time to clinical worsening endpoints [ Time Frame: 96 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Official Title  ICMJE 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
Brief Summary This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: Imatinib
200 mg or 400 mg qd
Study Arms  ICMJE Experimental: QTI571
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
Intervention: Drug: Imatinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 6, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2011)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Italy,   Lithuania,   United Kingdom,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT01392495
Other Study ID Numbers  ICMJE CQTI571A2102E1
2010-021960-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party External Affairs, Novartis Pharmaceuticals
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2015

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