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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001709
Receipt No. R000002063
Scientific Title Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension
Date of disclosure of the study information 2009/02/16
Last modified on 2009/02/14

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Basic information
Public title Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension
Acronym Multikinase Inhibitor for Pulmonary Arterial Hypertension
Scientific Title Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension
Scientific Title:Acronym Multikinase Inhibitor for Pulmonary Arterial Hypertension
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effects of multikinase inhibitor (sorafenib) for the treatment of severe pulmonary arterial hypertension, which is refractory for conventional therapies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes subjective symptom (WHO functional classification), 6 minutes walk test, echocardiography, right heart catheterization, serum BNP level
Key secondary outcomes

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 administration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with severe pulmonary arterial hypertension who are refractory for conventional therapies such as PGIS, Ca-blocker, bosentan, and sildenafil
Key exclusion criteria patients who can not express subjective symptoms, can not be evaluated through objective improvement, have the past history of thromboembolism, have the systemic hypertensive disease, have critical liver cirrhosis, are during pregnancy or during lactation, have critical left heart disease, or are receiving hemodialysis.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Satoh
Organization School of Medicine, Keio University
Division name Medical Education Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Medical Education Center
Zip code
Address
TEL
Homepage URL
Email m.kataoka@cpnet.med.keio.ac.jp

Sponsor
Institute Medical Education Center, School of Medicine, Keio University
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 16 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 Preinitiation
Date of protocol fixation
2009 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 14 Day
Last modified on
2009 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002063

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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