UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024861 |
|---|---|
| Receipt number | R000028610 |
| Scientific Title | A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2018/05/17 17:22:41 |
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Basic information
Public title
A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension
Acronym
A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension
Scientific Title
A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension
Scientific Title:Acronym
A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD) with hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Survey of the efficacy and safety of a antihypertensive drugs to the patients of Chronic Kidney Disease (CKD) with hypertension using the database of Drug Use-Result Surveys on antihypertensive drugs in RAD-AR Council Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Blood pressure
Key secondary outcomes
Blood pressure lowering effect, Examination of renal function level, Incidence of Event (Vascular brain disease, Cardiovascular disease, Kidney disease), Safety
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) The case by which the following condition is here more than 1.
(1) eGFR is less than 60 ml/min/1.73m2 at the beginning of administration
(2) Urine protein is more than positive+ at the beginning of administration
(3) Patient who has kidney disease for complication.
2) Patient not on dialysis..
3) Patient who treated with a antihypertensive drugs for more than 1 day.
Key exclusion criteria
None
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakamura |
Organization
Maruho Co., Ltd.
Division name
Medical Affairs Dept.
Zip code
Address
1-5-22 Nakatsu Kita-ku Osaka 531-0071, Japan
TEL
06(6371)8913
nakamura_ckf@mii.maruho.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taketoshi Onda |
Organization
RAD-AR (Risk/Benefit Assessment of Drugs-Analysis & Response) Council Japan
Division name
Database committee
Zip code
Address
Nihonbashi N Building 8F, 1-4-2 Nihonbashi horidomecho, Chuo-ku, Tokyo 103-0012, Japan
TEL
03(3663)8891
Homepage URL
onda@rad-ar.or.jp
Sponsor or person
Institute
RAD-AR Council Japan
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
None
Name of secondary funder(s)
None
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
該当なし
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
This research is carried out using a database which 24 drug use surveys conducted by a pharmaceutical companies were input.
Management information
Registered date
| 2016 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028610
