UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017284 |
|---|---|
| Receipt number | R000020055 |
| Scientific Title | Pharmacokinetics of Tolvaptan:Influence of portal hypertension |
| Date of disclosure of the study information | 2015/04/26 |
| Last modified on | 2015/04/26 05:15:38 |
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Basic information
Public title
Pharmacokinetics of Tolvaptan:Influence of portal hypertension
Acronym
Pharmacokinetics of Tolvaptan:Influence of portal hypertension
Scientific Title
Pharmacokinetics of Tolvaptan:Influence of portal hypertension
Scientific Title:Acronym
Pharmacokinetics of Tolvaptan:Influence of portal hypertension
Region
| Japan |
Condition
Condition
Decompensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the pharmacokinetics of Tolvaptan and portal hypertension.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between the pharmacokinetics of Tolvaptan and portal hypertension.
Key secondary outcomes
the relationship between the diuretic effect and the pharmacokinetics of Tolvaptan.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 ascites due to cirrhosis, poorly reacted by following conventional diuretics. 1)more than 40mg furosemide + more than 25mg spironolactone or 2)more than 20mg furosemide + more than 50mg spironolactone
Key exclusion criteria
(1)Hepatic encephalopathy
(2)Hepatocellular carcinoma vascular invasion is observed in hepatic vein trunk, portal vein trunk,or inferior vena cava
(3)NYHA Class 3 or more of heart disease
(4)anuria, urinary tract stenosis, stones, or tumors urinary excretion.
(5)Patients with cerebrovascular disease within 30 days.
(6)Patients with following laboratory values can be seen:Hb<8.0g/dl,T-bil> 4.0mg/dl,Cre>2.0mg/dl,serum Na>147mEq/l,serum K>5.5mEq/l
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Sagawa |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL
03-5923-3111
earai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Sagawa |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-Ku Tokyo, Japan
TEL
03-5923-3111
Homepage URL
earai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Nerima Hospital
Department of Gastroenterology
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
| 2015 | Year | 04 | Month | 26 | 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
| 2015 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the relationship between the pharmacokinetics of Tolvaptan and portal hypertension.
Management information
Registered date
| 2015 | Year | 04 | Month | 26 | Day |
Last modified on
| 2015 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020055
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
