UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006726 |
|---|---|
| Receipt number | R000007843 |
| Scientific Title | A study of Tolvaptan to investigate the pharmacokinetics and diuretic effect |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2011/11/04 16:18:53 |
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Basic information
Public title
A study of Tolvaptan to investigate the pharmacokinetics and diuretic effect
Acronym
A study of Tolvaptan to investigate the pharmacokinetics and diuretic effect
Scientific Title
A study of Tolvaptan to investigate the pharmacokinetics and diuretic effect
Scientific Title:Acronym
A study of Tolvaptan to investigate the pharmacokinetics and diuretic effect
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetics, diuretic effect and safety of tolvaptan in congestive heart failure patients with volume overload under 10 years old regardless of existing diuretics
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacokinetics
Key secondary outcomes
body weight, CTR, urinary output and safety
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
tolvaptan0.125mg/kg*2/day
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
| Not applicable |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. heart failure patients who are already administered diuretics due to congenital heart disease
2. patients who can keep using fixed-dose existing diuretics for 12 hours from the start of tolvaptan administration.
3. congestive heart failure patients with volume overload who have tachycardia, polypnea(>=40/min), central venous pressure(7-8mmHg) or pulmonary congestion (chest x-ray).
4. patients who are under 10 years old ( at the time of informed consent)
5. inpatient
Key exclusion criteria
1. patients who have circulation assist
2. patients who have diseases, complications or symptoms as follows:
*possibly hypovolemic
*hypertrophic cardiomyopathy
*hepatic coma
*severe diabetes
*anuria
*urinary stenosis, calculus or impairment of urinary excretion due to tumor
3. patients who have a history as follows:
*cerebrovascular disease (asymptomatic is excluded)
*patients who have a history of allergy against benzazepine
4. patients whose laboratory test are as follows(at least 1 item)
*total bilirubin >3.0mg/dL
*serum creatinine >3.0mg/dL
*serum Na >147mEq/L
*serum K >5.5mEq/L
5. patients who are judged to be inappropriate to this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Ueda |
Organization
Kanagawa Children's Medical Center
Division name
Cardiology
Zip code
Address
2-138-4 Mutsukawa Minami-ku Yokohama Kanagawa
TEL
045-711-2351
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Ueda |
Organization
Kanagawa Children's Medical Center
Division name
Cardiology
Zip code
Address
2-138-4 Mutsukawa Minami-ku Yokohama Kanagawa
TEL
045-711-2351
Homepage URL
hidueda@gmail.com
Sponsor or person
Institute
Kanagawa Children's Medical Center
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
| 2011 | Year | 11 | Month | 15 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2011 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007843
| 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 |
