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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-UMIN000025176 |
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Date of registration:
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15/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.
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Scientific title:
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Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. - Efficacy, tolerability, and safety of transition from beraprost to selexipag |
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Date of first enrolment:
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2017/01/01 |
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Target sample size:
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33 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028960 |
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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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Keiichi
ODAGIRI |
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Address:
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1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
431-3129
Japan |
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Telephone:
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053-435-2850 |
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Email:
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kodagiri@hama-med.ac.jp |
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Affiliation:
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Hamamatsu University School of Medicine Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics |
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Name:
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Keiichi
ODAGIRI |
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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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053-435-2850 |
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Email:
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kodagiri@hama-med.ac.jp |
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Affiliation:
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Hamamatsu University School of Medicine Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients who added newly concomitant drugs within last 3 months 2. Patients who is expected to intolerable selexipag 3. Patients who had clinically unstable right heart failure within the last 3 months
Age minimum:
16years-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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Medicine transition from beraprost to selexipag In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed. The maximum dose allowed is 1.6mg twice daily.
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Primary Outcome(s)
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Pulmonary arterial resistance (PVR) at week 24 from baseline
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Secondary Outcome(s)
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Other variables at week 24 from baseline (1) Right heart catheterization (PCWP, PAP, RVP, CO/CI) (2) NT-proBNP (3) WHO functional class
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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: 13/12/2016
Contact:
rinri@hama-med.ac.jp
The Ethics Committee of Hamamatsu University School of Medicine
053-435-2111
rinri@hama-med.ac.jp
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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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31/03/2022 |
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URL:
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