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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000001709 |
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Date of registration:
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16/02/2009 |
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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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Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension
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Scientific title:
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Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension - Multikinase Inhibitor for Pulmonary Arterial Hypertension |
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Date of first enrolment:
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2009/02/01 |
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Target sample size:
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10 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002063 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toru Satoh |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
Japan |
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Telephone:
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Email:
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Affiliation:
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School of Medicine, Keio University Medical Education Center |
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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m.kataoka@cpnet.med.keio.ac.jp |
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Affiliation:
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School of Medicine, Keio University Medical Education Center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: patients who can not express subjective symptoms, can not be evaluated through objective improvement, have the past history of thromboembolism, have the systemic hypertensive disease, have critical liver cirrhosis, are during pregnancy or during lactation, have critical left heart disease, or are receiving hemodialysis.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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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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administration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor)
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Primary Outcome(s)
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subjective symptom (WHO functional classification), 6 minutes walk test, echocardiography, right heart catheterization, serum BNP level
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/02/2010 |
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URL:
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