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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017284
Receipt No. 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

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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
Email 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
Email earai@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Department of Gastroenterology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020055

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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