UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035389
Receipt No. R000039915
Scientific Title Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension
Date of disclosure of the study information 2019/04/01
Last modified on 2020/06/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of dual initial combination therapy with macitentan plus riociguat
or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension
Acronym SETOUCHI PH study
Scientific Title Effects of dual initial combination therapy with macitentan plus riociguat
or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension
Scientific Title:Acronym SETOUCHI PH study
Region
Japan

Condition
Condition Pulmonary arterial hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of dual initial combination therapy with macitentan plus riociguat
or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension in a prospective randomized study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of change ratio of pulmonary vascular resistance eight month after the administration between two groups
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month
Interventions/Control_2 Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Mean pulmonary artery pressure greater than 25 mmHg and pulmonary artery wedge pressure less than 15 mmHg and pulmonary vascular resistance greater than 3 wood units within one month after giving consent
2) WHO-FC II or III
3) Age greater than 20 years at the time of giving consent
4) Patients who agree to be enrolled in the study with signed written informed consent
Key exclusion criteria 1) Patients without PAH
2) Patients treated with PAH-specific drugs
3) Patients treated with incompatible drug combination
4) Patients with bleeding or risk of bleeding
5) Patients with pregnancy or suspected pregnancy or patients with breast-feeding
6) Patients with atrial fibrillation
7) Patients with moderate renal dysfunction (serum creatinine 1.5 mg/dl)
8) Patients with moderate liver dysfunction (serum AST or ALT 2-fold of standard value)9) Patients with hypotension (systolic blood pressure less than 90 mmHg)
10) Patients with low cardiac output (cardiac index less than 2.0 l/min/m2
11) Patients included other clinical study
12) Patients recognized as inappropriate by attending physician
Target sample size 76

Research contact person
Name of lead principal investigator
1st name Kazufumi
Middle name
Last name Nakamura
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of Cardiovascular Medicine
Zip code 700-8558
Address 2-5-1, kita-ku, shikata-cho, okayama
TEL 086-235-7351
Email ichibun@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Akagi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of Cardiovascular Medicine
Zip code 700-8558
Address 2-5-1, kita-ku, shikata-cho, okayama
TEL 086-235-7351
Homepage URL
Email akagi-s@cc.okayama-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, kita-ku, shikata-cho, okayama
Tel 086-235-6938
Email mae6605@adm.okayama-u.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 呉共済病院(広島県)、香川大学病院(香川県)、徳島大学病院(徳島県)、国立病院機構岡山医療センター(岡山県)、名古屋大学病院(愛知県)、鹿児島大学病院(鹿児島県)、岐阜ハートセンター(岐阜県)、松山赤十字病院(愛媛県)、熊本大学病院(熊本県)、神戸大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 There is a plan to make individual participant data (IPD) and related data dictionaries available.
IPD sharing Plan description We will share IPD that underlie the results reported in the article after deidentification. The study protocol will be available. Data sharing will begin from 6 months and end 2 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data are available at UMIN-ICDR https://www.umin.ac.jp/icdr/index-j.html.


Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 28 Day
Date of IRB
2019 Year 01 Month 15 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2026 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
2018 Year 12 Month 28 Day
Last modified on
2020 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039915

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.