UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025176 |
|---|---|
| Receipt number | R000028960 |
| Scientific Title | Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2022/06/13 15:12:09 |
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Basic information
Public title
Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.
Acronym
Efficacy, tolerability, and safety of transition from beraprost to selexipag
Scientific Title
Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.
Scientific Title:Acronym
Efficacy, tolerability, and safety of transition from beraprost to selexipag
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of transition from beraprost to selexipag on pulmonary arterial resistance (PVR) at week 24 from baseline in patients with pulmonary arterial hypertension.
Basic objectives2
Others
Basic objectives -Others
Tolerability (Dropout cases) and safety (adverse effects)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary arterial resistance (PVR) at week 24 from baseline
Key secondary outcomes
Other variables at week 24 from baseline
(1) Right heart catheterization (PCWP, PAP, RVP, CO/CI)
(2) NT-proBNP
(3) WHO functional class
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pulmonary arterial hypertension who had received beraprost for > 3 months.
2. Patients with pulmonary arterial hypertension who have a pulmonary vascular resistance of at least 5 Wood units (400 dyn･sec･cm-5)
3. Patients with pulmonary arterial hypertension who give a written informed consent.
Key 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
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | ODAGIRI |
Organization
Hamamatsu University School of Medicine
Division name
Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics
Zip code
431-3129
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2850
kodagiri@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | ODAGIRI |
Organization
Hamamatsu University School of Medicine
Division name
Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics
Zip code
431-3129
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL
053-435-2850
Homepage URL
kodagiri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
Tel
053-435-2111
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学（静岡県）、静岡県立大学（静岡県）、浜松赤十字病院（静岡県）、JA静岡厚生連 遠州病院 （静岡県）、聖隷浜松病院 （静岡県）、磐田市立総合病院（静岡県）、菊川市立病院 （静岡県）、聖隷三方原病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028960
