UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015215 |
|---|---|
| Receipt number | R000017554 |
| Scientific Title | Pleotropic effects of cilnidipine in patients with hypertension |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2016/02/09 23:13:54 |
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Basic information
Public title
Pleotropic effects of cilnidipine in patients with hypertension
Acronym
Pleotropic effects of cilnidipine
Scientific Title
Pleotropic effects of cilnidipine in patients with hypertension
Scientific Title:Acronym
Pleotropic effects of cilnidipine
Region
| Japan |
Condition
Condition
Patients with hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the blood pressure lowering and pleiotropic effects of cilnidipine in patients with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure lowering effects
Key secondary outcomes
Pleiotropic effects
Base
Study type
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB/amlodipine is switched to ARB/ cilnidipine
Interventions/Control_2
ARB/ cilnidipine is switched to ARB/amlodipine
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients with ARB/ amlodipine
Key exclusion criteria
Patients with no consensus
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shusuke Yagi |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima-city, Tokushima
TEL
088-633-7851
syagi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusuke Yagi |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima-city, Tokushima
TEL
088-633-7851
Homepage URL
syagi@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School of Health Biosciences
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 09 | Month | 20 | Day |
Last modified on
| 2016 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017554
| 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 |
