Trial record 4 of 6 for:    QTI571

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

This study has been terminated.
(Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: July 11, 2011
Last updated: July 13, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Patients With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
    Adverse event monitoring was conducted throughout the trial.

Secondary Outcome Measures:
  • Change From Baseline in the Six Minute Walk Distance (6MWD) [ Time Frame: baseline, 144 weeks ] [ Designated as safety issue: No ]
  • Time to Clinical Worsening (TTCW) Endpoints [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
  • Medical Resource Utilization [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QTI571
Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
Drug: Imatinib
200 mg or 400 mg qd


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT01392495

United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01392495     History of Changes
Other Study ID Numbers: CQTI571A2102E1, 2010-021960-14
Study First Received: July 11, 2011
Results First Received: March 24, 2015
Last Updated: July 13, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Pulmonary arterial hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 27, 2015