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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006212
Receipt No. R000007328
Scientific Title A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Date of disclosure of the study information 2011/08/22
Last modified on 2011/08/22

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Basic information
Public title A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Acronym A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Scientific Title A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Scientific Title:Acronym A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the diuretic effect of tolvaptan with existing diuretics
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Body weight
Key secondary outcomes edema
CTR
Ejection fraction
plasma BNP level

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 tolvaptan 7.5mg/day (can be escalated to 15mg, if needed)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.patients who satisfy inclusion criteria as follows at the screening test
2.congestive heart failure patients who are already administered diuretics
3.patients with proteinuria and edema
4.inpatients
Key exclusion criteria 1.patients who have a history of allergens against tolvaptan or similar compounds
2.anuric patients (urinary output: <100mL/day)
3.patients who cannnot feel thirsty or have difficulty to drink
4.patients whose serum sodium level is over 147mEq/L
5.pregnant or possibly pregnant woman
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazo Kaizu
Organization Social Insurance Yokohama Central Hospital
Division name Department of Nephrology and Blood purification
Zip code
Address 268, Yamashita-cho, Naka-ku, Yokohama, Kanagawa, Japan
TEL 045-641-1921
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazo Kaizu
Organization Social Insurance Yokohama Central Hospital
Division name Department of Nephrology and Blood purification
Zip code
Address 268, Yamashita-cho, Naka-ku, Yokohama, Kanagawa, Japan
TEL 045-641-1921
Homepage URL
Email

Sponsor
Institute Social Insurance Yokohama Central Hospital
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
2011 Year 08 Month 22 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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 08 Month 22 Day
Last modified on
2011 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007328

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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