UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051525 |
|---|---|
| Receipt number | R000058784 |
| Scientific Title | Analysis of factors associated with blood pressure reductions in hypertensive patients treated with esaxerenone -Integrated analysis from esaxerenone clinical studies- |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2025/02/12 16:36:15 |
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Basic information
Public title
Analysis of factors associated with blood pressure reductions in hypertensive patients treated with esaxerenone
-Integrated analysis from esaxerenone clinical studies-
Acronym
Integrated analysis from esaxerenone clinical studies
Scientific Title
Analysis of factors associated with blood pressure reductions in hypertensive patients treated with esaxerenone
-Integrated analysis from esaxerenone clinical studies-
Scientific Title:Acronym
Integrated analysis from esaxerenone clinical studies
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone by integrating data from its clinical studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors associated with change in morning BP (systolic BP and diastolic BP) from baseline to end of treatment (Week 12)
Key secondary outcomes
Secondary endpoint;
Factors associated with change in bedtime BP and office sitting BP (systolic BP and diastolic BP) from baseline to end of treatment (Week 12)
Safety endpoint;
Factors associated with number of patients with serum potassium elevation (5.5 mEq/L and more) to Week 12
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled to esaxerenone clinical studies (5 studies in total)
Key exclusion criteria
Not applicable
Target sample size
493
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kimura |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Taguchi |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
taguchi.takashi.ft@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, 180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39090179/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39090179/
Number of participants that the trial has enrolled
493
Results
The factors associated with a strong BP-lowering effect of esaxerenone
Morning home BP
-Female
-Use of RAS inhibitors as a basal antihypertensive drug
-Office pulse rate(beats/min):<60
-UACR(mg/gCr):30to<300
Bedtime home BP
-Female
-Use of RAS inhibitors as a basal antihypertensive drug
Safety Endpoint
Patients with baseline serum potassium levels of 4.5 mEq/L and more had an increased risk of developing elevated serum potassium levels(5.5mEq/L and more) after esaxerenone treatment
Results date posted
| 2025 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline Characteristics(FAS:479patients)
-Male:57.8%
-Mean Age:66.5years, plus or minus 11.3years.
-BMI:25.9kg/m2, plus or minus 4.2kg/m2
-Morning home BP:
Systolic BP: 138.4mmHg, plus or minus 12.1 mmHg
Diastolic BP: 83.5mmHg, plus or minus 10.5 mmHg
-eGFRcreat:66.0 mL/min/1.73 m2, plus or minus 18.1 mL/min/1.73 m2
-Serum Potassium:4.2mEq/L, plus or minus 0.4 mEq/L
-Prevalence of Diabetes: 58.2%
-Basal antihypertensive drugs:
RAS inhibitor: 41.3%
Calcium Channel Blocker (CCB): 34.2%
RAS inhibitor/CCB: 24.4%
Participant flow
This study utilized data from registered patients in a domestic specific clinical study for esaxerenone (five clinical studies).
FAS (Full Analysis Set): 479 patients
Safety Analysis Set: 492 patients
Adverse events
N/A
Outcome measures
Blood Pressure Change
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Integrated analysis from esaxerenone clinical studies
Management information
Registered date
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058784
