UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013626 |
|---|---|
| Receipt number | R000015300 |
| Scientific Title | The effect of ciLnidipine On iNtra- and inter- Dialytic blOod pressure in iNtradialytic hypertensive patients: open-label randomized control trial |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2018/04/06 16:52:37 |
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Basic information
Public title
The effect of ciLnidipine On iNtra- and inter- Dialytic blOod pressure in iNtradialytic hypertensive patients: open-label randomized control trial
Acronym
LONDON study
Scientific Title
The effect of ciLnidipine On iNtra- and inter- Dialytic blOod pressure in iNtradialytic hypertensive patients: open-label randomized control trial
Scientific Title:Acronym
LONDON study
Region
| Japan |
Condition
Condition
chronic hemodialytic patients
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether cilnidipine inhibits intradialytic hypertension and sympathetic overactivity in patients with intradialytic hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intradialytic blood pressure elevation during hemodialysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilnidipine
Interventions/Control_2
control
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been on chronic hemodialysis with any causes and are older than 20 years old can be eligible for this study.
Key exclusion criteria
Patients who have pre-hemodialysis blood pressure<120 mmHg, symptom of heart failure, ischemic heart disease, malignancy disease, severe heart valve disease, or infectious disease. Patients who can not wear 24 h-ABPM.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Ito |
Organization
Mie University Graduate School of Medicine
Division name
Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
+81-59-232-1111
mitoka@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayasu Ito |
Organization
Mie University Graduate School of Medicine
Division name
Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
+81-59-232-1111
Homepage URL
takayasu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
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
武内病院（三重県）、尾鷲総合病院（三重県）、遠山病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2018 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015300
