UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001709 |
|---|---|
| Receipt number | 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 00:19:52 |
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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
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
m.kataoka@cpnet.med.keio.ac.jp
Sponsor or person
Institute
Medical Education Center, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002063
