UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047026 |
|---|---|
| Receipt number | R000053648 |
| Scientific Title | Analysis of factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone (CS-3150) -Integrated analysis from CS-3150 phase 3 studies- |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/01/25 17:06:28 |
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Basic information
Public title
Analysis of factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone (CS-3150)
-Integrated analysis from CS-3150 phase 3 studies-
Acronym
Analysis of factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone (CS-3150)
Scientific Title
Analysis of factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone (CS-3150)
-Integrated analysis from CS-3150 phase 3 studies-
Scientific Title:Acronym
Analysis of factors associated with blood pressure reduction and serum potassium elevation in hypertensive patients treated with esaxerenone (CS-3150)
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 phase 3 studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy endpoint;
Change in office sitting BP (systolic BP and diastolic BP) from baseline to Week 12
Safety endpoint;
Number of patients with following serum potassium levels
(1) 5.5 mEq/L and more
(2) 6.0 mEq/L and more, or 5.5 mEq/L and more on two consecutive occasions
Key secondary outcomes
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 assigned to the CS-3150 group in phase 3 studies (7 studies in total)
Key exclusion criteria
Not applicable
Target sample size
1470
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 | Kotaro |
| Middle name | |
| Last name | Sugimoto |
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
sugimoto.kotaro.t7@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
Kitamachi clinic
Address
1-1-3 Kichijoji Kitamachi, Musashino, Tokyo
Tel
070-5011-8550
shingo-namiki@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
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36662393/
Number of participants that the trial has enrolled
1472
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 20 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Integrated analysis from CS-3150 phase 3 studies
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053648
