UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008257 |
|---|---|
| Receipt number | R000009734 |
| Scientific Title | A study to evaluate the efficacy and safety of Tolvaptan and Carperitide in HF patients |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/06/26 01:02:54 |
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Basic information
Public title
A study to evaluate the efficacy and safety of Tolvaptan and Carperitide in HF patients
Acronym
A study to evaluate the efficacy and safety of Tolvaptan and Carperitide in HF patients
Scientific Title
A study to evaluate the efficacy and safety of Tolvaptan and Carperitide in HF patients
Scientific Title:Acronym
A study to evaluate the efficacy and safety of Tolvaptan and Carperitide in HF patients
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in urine volume
Key secondary outcomes
Congestive symptoms, renal function, neurohumoral factors, safety and cardiovascular events
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 7.5-15mg/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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) inpatients due to acute heart failure
(2) patients with lack of efficacy regardless of carperitide 0.0125ug/min (or 0.025ug/min)
(3) ability of oral administration
(4) male or female who are over 20 years old at the time of informed consent
(5) ability to provide written informed consent
Key exclusion criteria
(1) history of allergy against this drug or similar compounds
(2) anuric patients
(3) patients who cannot feel thirsty or have difficulty to drink
(4) hypernatremia patients
(5) patients who are pregnant or possibly pregnant
(6) patients who already have tolvaptan at entry
(7) acute myocardial infarction patients or planned revascularization during study period
(8) patiets who administer intravenous diuretics except carperitide
(9) patients who are judged to be inappropriate to this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Iwaki |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of cardiology
Zip code
Address
132 Katsura-cho Sakae-ku Yokohama Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of cardiology
Zip code
Address
132 Katsura-cho Sakae-ku Yokohama Kanagawa
TEL
045-891-2171
Homepage URL
iwaki4661@yahoo.co.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
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
| 2012 | Year | 07 | Month | 01 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2012 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009734
