UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017361 |
|---|---|
| Receipt number | R000020149 |
| Scientific Title | Comparison between amlodipine and benidipine on prognosis among patients after hypertensive heart failure |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2022/05/06 09:19:28 |
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Basic information
Public title
Comparison between amlodipine and benidipine on prognosis among patients after hypertensive heart failure
Acronym
Amlodipine or benidipine after hypertensive heart failure
Scientific Title
Comparison between amlodipine and benidipine on prognosis among patients after hypertensive heart failure
Scientific Title:Acronym
Amlodipine or benidipine after hypertensive heart failure
Region
| Japan |
Condition
Condition
hypertensive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of amlodipine and benidipine as a second prevention drug for hypertensive heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrent rate of hospitalization due to heart failure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amlodipine
Interventions/Control_2
Benidipine
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Systolic blood pressure was above 160 mmHg with acute pulmonary edema when hospitalized.
2. above 20 y.o. and below 80 y.o.
3. Able to take oral medicine.
4. a. Systolic blood pressure is above 130 mmHg or diastolic blood pressure is above 80 mmHg. or, b. Continuing drip injection of calcium channel blocker.
5. Able to understand informed consent.
Key exclusion criteria
1. History of adverse effect on calcium channel blocker.
2. Concomitant serious cardiac diseases.
3. Hemodialysis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arihiro Kiyosue |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
kiyosue-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arihiro Kiyosue |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
kiyosue-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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 | 05 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020149
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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