UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037721 |
|---|---|
| Receipt number | R000042941 |
| Scientific Title | Effects of adding esaxerenone to calcium channel blocker in patients with essential hypertension. |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2022/02/21 16:06:14 |
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Basic information
Public title
Effects of adding esaxerenone to calcium channel blocker in patients with essential hypertension.
Acronym
Effects of adding esaxerenone to calcium channel blocker in patients with essential hypertension.
Scientific Title
Effects of adding esaxerenone to calcium channel blocker in patients with essential hypertension.
Scientific Title:Acronym
Effects of adding esaxerenone to calcium channel blocker in patients with essential hypertension.
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of antihypertensive and organ protective effects of esaxelenone compared to losartan potassium.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood pressure, pulse rate, serum levels of potassium and creatinine, and eGFR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
esaxerenone 24 weeks
Interventions/Control_2
losartan potassium 24 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with essential hypertension.
Patients who have been taking calcium channel blocker for more than 8 weeks but still have poor blood pressure control.
Key exclusion criteria
Patients taking antihypertensive drugs other than calcium channel blocker during the last 8 weeks.
Patients with systolic blood pressure>=160 mmHg and/or diastolic blood
pressure>=100 mmHg.
Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2).
Patients with unstable angina.
Patients with a history of myocardial infarction or stroke within 24 weeks.
Patients with severe liver dysfunction.
Pregnant or lactating women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Ichihara |
Organization
Tokyo Women's Medical University
Division name
Department of Endocrinology and Hypertension
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
atzichihara@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Nobukazu |
| Middle name | |
| Last name | Sasaki |
Organization
Tokyo Women's Medical University
Division name
Department of Endocrinology and Hypertension
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
sasaki.nobukazu@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's 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
Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
inai.kiyoshi@twmu.ac.jp
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
| 2019 | Year | 08 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
