UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057149 |
|---|---|
| Receipt number | R000065333 |
| Scientific Title | Clinical study associated with antihypertensive drug Change to ARB and ARNI in Patients with High Renin Hypertension |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/06/18 11:16:50 |
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Basic information
Public title
Clinical study associated with antihypertensive drug Change to ARB and ARNI in Patients with High Renin Hypertension
Acronym
Clinical study associated with antihypertensive drug Change to ARB and ARNI in Patients with High Renin Hypertension
Scientific Title
Clinical study associated with antihypertensive drug Change to ARB and ARNI in Patients with High Renin Hypertension
Scientific Title:Acronym
Clinical study associated with antihypertensive drug Change to ARB and ARNI in Patients with High Renin Hypertension
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate in our patients with hyperreninemic hypertension how renin activity is altered by changing drugs from aliskiren, a selective renin inhibitor, to an angiotensin II receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNI).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in renin
Key secondary outcomes
Aldosterone, urinary albumin, urinary protein, eGFR, NT-proBNP, catecholamine
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
Switch from aliskiren to valsartan 40 mg. If the patient does not achieve adequate antihypertensive effect after approximately 2 months of observation, switch to sacubitril valsartan 100 mg. If the patient does not achieve adequate antihypertensive effect after another 2 months of observation, the patient is switched to sacubitril valsartan 200 mg.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The patient is being treated for hypertension with aliskiren.
2) The patient is at least 18 years of age at the time of consent.
3) The patient has given written consent to participate in the study.
Key exclusion criteria
1) Diagnosed with primary renal disease (glomerulonephritis, polycystic kidney disease)
2) History of hypersensitivity to valsartan, sacubitril valsartan, or any of the ingredients contained in these products.
3) History of angioedema.
4) Severe hepatic dysfunction (Child-Pugh Classification C).
5) Pregnant women or women who may be pregnant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Kobayashi |
Organization
Shimane University Hospital
Division name
Endocrinology
Zip code
693-8501
Address
89-1 Ennya-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2183
m.shibao@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kobayashi |
Organization
Shimane University Hospital
Division name
Endocrinology
Zip code
693-8501
Address
89-1 Ennya-cho, Izumo City, Shimane Prefecture
TEL
0853-20-2183
Homepage URL
m.shibao@med.shimane-u.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
not
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
Shimane University Hospital
Address
89-1 Ennya-cho, Izumo City, Shimane Prefecture
Tel
0853-20-2183
m.shibao@med.shimane-u.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
| 2025 | Year | 02 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065333
