UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028158 |
|---|---|
| Receipt number | R000032232 |
| Scientific Title | CAN we converT to tofogliflozin hydrate instead of diuretic AnTi-hypeRtensive medicine In type 2 diabetiC patiEnts associated with hypertension? |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2018/09/05 11:41:03 |
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Basic information
Public title
CAN we converT to tofogliflozin hydrate instead of diuretic AnTi-hypeRtensive medicine In type 2 diabetiC patiEnts associated with hypertension?
Acronym
CANTATRICE Study
Scientific Title
CAN we converT to tofogliflozin hydrate instead of diuretic AnTi-hypeRtensive medicine In type 2 diabetiC patiEnts associated with hypertension?
Scientific Title:Acronym
CANTATRICE Study
Region
| Japan |
Condition
Condition
Hypertension associated with type 2 diabetic mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate safety and effectiveness of tofogliflozin when is converted from diuretic anti-hypertensive medicines in patients of hypertension associated with type 2 of diabetic mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
pulse rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prescription of tofogliflozin instead of anti-hypertensive diuretics
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Poor controlled patients of type 2 diabetic mellitus who are taking antihypertensive diuretics including combined medicines with diuretics , and also to be considered reasonable and proper for prescription of SGLT3 inhibitors. Among these patients treating with oral diabetic medicines and in follow-up patients include.
Key exclusion criteria
Patients who are pregnant or possibility of pregnancy, uncontrolled blood pressure, over 80 yrs old, frailty, hypersensitivity of SGLT2 inhibitor, shows over 1000 U of AST or ALT, less than 45ml/min/1.73m2 of eGFR, or who are inadequate judged by physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Mori |
Organization
Kanagawa Association of Medical and Dental Practitioners
Division name
Department of Clinical Research
Zip code
Address
2F,TS Plaza-Building,2-23-2,Tsuruya-Cho,Kanagawa-Ku,Yokohama City,Japan 221-0835
TEL
045-313-2111
hmori@gem.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma katsumata |
Organization
Kanagawa Association of Medical and Dental Practitioners
Division name
Department of Clinical Research
Zip code
Address
2F,TS Plaza-Building,2-23-2,Tsuruya-Cho,Kanagawa-Ku,Yokohama City,Japan 221-0835
TEL
045-313-2111
Homepage URL
Katsumata.t@doc-net.or.jp
Sponsor or person
Institute
Department of Clinical Research Kanagawa Association of Medical and Dental Practitioners
Institute
Department
Personal name
Funding Source
Organization
Aggregate Corporation Japanese Association of Clinical Investigation
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 07 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032232
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
