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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019599
Receipt No. R000022657
Scientific Title Effect of Riocigat on Patients with Chronic Thromboembolic Pulmonary Hypertension after Balloon Pulmonary Angioplasty
Date of disclosure of the study information 2015/11/02
Last modified on 2019/11/18

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Basic information
Public title Effect of Riocigat on Patients with Chronic Thromboembolic Pulmonary Hypertension after Balloon Pulmonary Angioplasty
Acronym Effect of Riocigat on Patients with CTEPH after BPA
Scientific Title Effect of Riocigat on Patients with Chronic Thromboembolic Pulmonary Hypertension after Balloon Pulmonary Angioplasty
Scientific Title:Acronym Effect of Riocigat on Patients with CTEPH after BPA
Region
Japan

Condition
Condition Chronic thromboembolic pulmonary hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of riocigat on exercise capasity in patients with chronic thromboembolic pulmonary hypertension after catheter intervantion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Six minutes walk distance 6 months later
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Riocigat, 1.5mg to 7.5mg, for 6 months
Interventions/Control_2 control
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 Patients diagnosed as CTEPH
Patietns with symptom of NYHA 1 or 2
Patients showing 20 to 30 mmHg of mean pulmonary arterial pressure or 200 to 400 dyne of pulmonary vascular resistance afetr BPA
Key exclusion criteria Patients with unstable hemodynamics
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular Medicine
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7153
Email shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Tatsuo
Middle name
Last name Aoki
Organization Tohoku University Graduate School of Medicine
Division name Cardiovascular Medicine
Zip code 9808574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7153
Homepage URL
Email t.aoki@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization the Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Institutional review board in Tohoku University School of Medicine
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
Tel 022-717-7000
Email hosp-ken@grp.tohoku.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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 02 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 21
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
2015 Year 10 Month 29 Day
Date of IRB
2015 Year 03 Month 24 Day
Anticipated trial start date
2015 Year 11 Month 02 Day
Last follow-up date
2019 Year 07 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
2015 Year 11 Month 02 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022657

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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