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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01392495 |
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Date of registration:
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11/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
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Scientific title:
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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 |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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17 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01392495 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Germany
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Italy
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Lithuania
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Imatinib
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Primary Outcome(s)
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Number of Patients With Adverse Events, Serious Adverse Events and Deaths
[Time Frame: 144 weeks]
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Secondary Outcome(s)
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Medical Resource Utilization
[Time Frame: 144 weeks]
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Change From Baseline in the Six Minute Walk Distance (6MWD)
[Time Frame: baseline, 144 weeks]
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Time to Clinical Worsening (TTCW) Endpoints
[Time Frame: 144 weeks]
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Secondary ID(s)
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CQTI571A2102E1
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2010-021960-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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