UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054921 |
|---|---|
| Receipt number | R000062601 |
| Scientific Title | Analysis of the efficacy and safety of esaxerenone with or without SGLT2 inhibitors in hypertensive patients with diabetes -Integrated analysis from esaxerenone clinical studies- |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2025/09/17 10:27:59 |
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Basic information
Public title
Analysis of the efficacy and safety of esaxerenone with or without SGLT2 inhibitors in hypertensive patients with diabetes -Integrated analysis from esaxerenone clinical studies-
Acronym
Integrated analysis of esaxerenone with or without SGLT2i
Scientific Title
Analysis of the efficacy and safety of esaxerenone with or without SGLT2 inhibitors in hypertensive patients with diabetes -Integrated analysis from esaxerenone clinical studies-
Scientific Title:Acronym
Integrated analysis of esaxerenone with or without SGLT2i
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 analyze its efficacy and safety in hypertensive patients with diabetes treated with esaxerenone by integrating date from its clinical studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in morning home BP (systolic BP and diastolic BP) from baseline to Week 12
Key secondary outcomes
Efficacy endopoint
･Change in bed-time home BP and office-sitting BP
･Changes in each blood pressure
･Achieving rate of target blood pressure
･Change and %change in UACR
･Change and %change in NT-proBNP
Safety endpoint
･Number of patients with serum potassium elevation (5.5 mEq/L and more)
･Change and Change from baseline in serum potassium levels and eGFR
･Adverse events
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
279
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
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
yasuda.yoshi.gn@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Suedomi |
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
suedomi.tomohiro.f4@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
| 2024 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40890417/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40890417/
Number of participants that the trial has enrolled
279
Results
Change in morning home BP (systolic BP/diastolic BP) from baseline at Week 12
Overall: -11.9/-5.2 mmHg
With SGLT2i: -11.3/-4.8 mmHg
Without SGLT2i: -12.5/-5.7 mmHg
Safety Endpoint
Incidence of serum potassium level >=5.5 mEq/L within 12 weeks after study drug administration
Overall: 3.5% (10/283 patients)
With SGLT2i: 2.0% (3/148 patients)
Without SGLT2i: 5.2% (7/135 patients)
*SGLT2i(Sodium-glucose cotransporter-2 inhibitor)
Results date posted
| 2025 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 09 | Month | 01 | Day |
Baseline Characteristics
Baseline Characteristics (FAS: 279 patients)
-Male: 59.5%
-Mean Age: 67.9 years, plus or minus 10.2 years
-BMI: 26.4 kg/m2, plus or minus 4.1 kg/m2
-Morning home BP:
Systolic BP: 137.4 mmHg, plus or minus 11.7 mmHg
Diastolic BP: 81.1 mmHg, plus or minus 10.3 mmHg
-Diabetes drug class:
SGLT2i: 52.0%
-eGFRcreat: 61.7 mL/min/1.73 m2, plus or minus 18.2 mL/min/1.73 m2
-Serum Potassium: 4.2 mEq/L, plus or minus 0.4 mEq/L
Participant flow
This study utilized data from registered patients in a domestic specific clinical study for esaxerenone (five clinical studies).
FAS (Full Analysis Set): Hypertensive patients with type 2 diabetes mellitus: 279 patients (with SGLT2i, 145; without SGLT2i, 134)
Safety Analysis Set: Hypertensive patients with type 2 diabetes mellitus: 283 patients (with SGLT2i, 148; without SGLT2i, 135)
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
･ Efficacy and Safety of Esaxerenone in Hypertensive Patients with Left Ventricular Hypertrophy. (ESES-LVH study) (jRCTs071190043)
･ Efficacy and Safety of Esaxerenone in hypertensive patients with diabetic kidney disease : a single-arm, open-label study. (EX-DKD study) (jRCTs061190027)
･ Clinical Study to Assess the Efficacy and Safety of Esaxerenone in Patients with Type 2 Diabetes Mellitus and Hypertension using Sodium Glucose Co-transporter 2 Inhibitor. (EAGLE-DH study) (jRCTs031200273)
･ An Exploratory Study of the Efficacy and Safety of Esaxerenone in Uncontrolled Nocturnal Hypertensive Patients : a single-arm, open-label study. (EARLY-NH study) (jRCTs031200364)
･ An exploratory study to assess the antihypertensive effect of Esaxerenone in hypertensive patients, and its correlation with Urinary Na / K ratio or salt intake. (ENaK study) (jRCTs031210273)
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062601
