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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025176
Receipt No. 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 2017/01/04

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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
Middle name
Last name Keiichi ODAGIRI
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics
Zip code
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
Middle name
Last name Keiichi ODAGIRI
Organization Hamamatsu University School of Medicine
Division name Center for Clinical Research/ Department of Clinical Pharmacology and Therapeutics
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
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
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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