UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057642 |
|---|---|
| Receipt number | R000065861 |
| Scientific Title | A Prospective Single-Arm Study to Evaluate the Effects of Sacubitril/Valsartan Sodium on Vascular Endothelial Function in Patients with Hypertension and Diabetes Mellitus |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/04/17 15:47:25 |
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Basic information
Public title
A Prospective Study on the Effects of Sacubitril/Valsartan Sodium on Vascular Endothelial Function in Hypertensive Patients with Diabetes Mellitus
Acronym
A Prospective Study on the Effects of Sacubitril/Valsartan Sodium on Vascular Endothelial Function in Hypertensive Patients with Diabetes Mellitus
Scientific Title
A Prospective Single-Arm Study to Evaluate the Effects of Sacubitril/Valsartan Sodium on Vascular Endothelial Function in Patients with Hypertension and Diabetes Mellitus
Scientific Title:Acronym
A Prospective Single-Arm Study to Evaluate the Effects of Sacubitril/Valsartan Sodium on Vascular Endothelial Function in Patients with Hypertension and Diabetes Mellitus
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether there is a difference in FMD before and after the use of sacubitril valsartan sodium in subjects with diabetes mellitus complicated by hypertension. The effect on glucose tolerance will also be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in FMD values before and after the use of sacubitril valsartan sodium in diabetic patients with hypertension
Key secondary outcomes
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
Sacubitril valsartan will be administered for a total of 48 weeks. Dosage is for use as per the package insert.
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 age 20 years and older
Key exclusion criteria
1)Those who refused to participate in the study
2)Those not indicated for sacubitril valsartan
3) Patients with severe hepatic impairment
4)Other patients deemed inappropriate by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
761-0793
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
saheki.takanobu@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
7610301
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
Homepage URL
saheki.takanobu@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Research Support Center, Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
087-898-5111
chiken-m@kagawa-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 | 04 | Month | 17 | 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
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065861
