UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035389 |
|---|---|
| Receipt number | 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 | 2024/01/04 10:00:34 |
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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
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
akagi-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department
Personal name
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
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）、鹿児島大学病院（鹿児島県）、松山赤十字病院（愛媛県）、熊本大学病院（熊本県）、長崎大学病院（長崎県）、京都大学病院（京都府）、福岡大学病院（福岡県）、名古屋大学病院（愛知県）
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
| 2029 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039915
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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