UMIN-CTR Clinical Trial

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
Email	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
Email	kodagiri@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028960