UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022109 |
|---|---|
| Receipt number | R000025487 |
| Scientific Title | Effect of Empagliflozin on Ambulatory Blood Pressure Monitoring (ABPM) |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2016/04/27 21:20:59 |
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Basic information
Public title
Effect of Empagliflozin on Ambulatory Blood Pressure Monitoring (ABPM)
Acronym
Effect of Empagliflozin on ABPM
Scientific Title
Effect of Empagliflozin on Ambulatory Blood Pressure Monitoring (ABPM)
Scientific Title:Acronym
Effect of Empagliflozin on ABPM
Region
| Japan |
Condition
Condition
Diabetics Mellitus
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Empagliflozin on 24 hour blood pressure changes by using ABPM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of 24 hour blood pressure
Key secondary outcomes
Changes of fast blood glucose and HbA1c
Change of renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Empagliflozin
Interventions/Control_2
DPP4 Inhibitor
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with DM and Hypertension
Key exclusion criteria
eGFR<30ml/min/1.73m2
Liver Dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Internal Medicine
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
nakamo_h@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Internal Medicine
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1667
Homepage URL
nakamo_h@saitama-med.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Saitama Medical University
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
埼玉医科大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025487
