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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024861
Receipt No. 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

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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
Email 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
Email onda@rad-ar.or.jp

Sponsor
Institute RAD-AR Council Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028610

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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