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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-UMIN000005464 |
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Date of registration:
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19/04/2011 |
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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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Drug interactions and effects of combination therapy for pulmonary arterial hypertension
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Scientific title:
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Drug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy |
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Date of first enrolment:
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2011/04/01 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006480 |
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Study type:
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Interventional |
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Study design:
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Factorial Non-randomized
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Phase:
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Not applicable
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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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Kazuhiko Takeuchi |
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Address:
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1-20-1 Handayama Higashi-ku Hamamatsu Japan
Japan |
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Telephone:
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053-435-2385 |
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Email:
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Affiliation:
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Hamamatsu University School of Medicine Clinical Pharmacology and Therapeutics |
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Name:
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Kazuhiko Takeuchi |
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Address:
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1-20-1 Handayama Higashi-ku Hamamatsu Japan
Japan |
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Telephone:
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053-435-2385 |
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Email:
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takeutik@hama-med.ac.jp |
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Affiliation:
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Hamamatsu University School of Medicine Clinical Pharmacology and Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Unstable disease conditions. Disabilities of walk. Home oxygen therapy. Ineligible patients judged by principal. investigator.
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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phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks
phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
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Primary Outcome(s)
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Pharmacokinetics in the last week of each phase: sildenafil, bosentan, ambrisentan and tadalafil. Exercise tolerability test: 6 minute walk test, shattle walking test and maximal oxygen consumption test.
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Source(s) of Monetary Support
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Hamamatsu University School of Medicine
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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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01/03/2014 |
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URL:
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