UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061780 |
|---|---|
| Receipt number | R000070696 |
| Scientific Title | A Randomized Trial for Comparison of Blood Pressure between Sacubitril/Valsartan and Thiazide Diuretics in Patients with Uncontrolled Hypertension. A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 13:00:57 |
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Basic information
Public title
A trial to evaluate the efficacy and safety of Sacubitril/valsartan treatment in patients with difficult-to-control hypertension
Acronym
Sacubitril/Valsartan Blood Pressure Study
Scientific Title
A Randomized Trial for Comparison of Blood Pressure between Sacubitril/Valsartan and Thiazide Diuretics in Patients with Uncontrolled Hypertension. A Randomized Controlled Trial
Scientific Title:Acronym
COMBAT-R Trial
Region
| Japan |
Condition
Condition
Patients with essential hypertension who have poor blood pressure control despite combination therapy with ARBs and CCBs
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of adding Sacubitril/Valsartan to the regimen in patients with uncontrolled hypertension despite combination therapy with angiotensin II receptor blockers (ARBs) and calcium channel blockers (CCBs), compared with adding a diuretic.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Percentage of patients achieving the target blood pressure in the clinic at the final evaluation (Week 12)
Key secondary outcomes
1)Achievement rate of morning home blood pressure at the final assessment (Week 12)
2)Change from baseline to the final assessment (Week 12) in the following clinical data
3)Office blood pressure, morning blood pressure, clinical findings (weight, pulse, eGFR, uric acid, serum potassium, HbA1c, albuminuria or proteinuria (all per gram of creatinine), estimated salt intake based on sodium, potassium, and creatinine concentrations in spot urine (using the Tanaka formula), and sodium-to-potassium ratio, AST, ALT, gamma-GTP, LDL cholesterol, HDL cholesterol, triglycerides
4)Nighttime blood pressure at the final evaluation (for the implementation example only)
5)Safety evaluation (adverse events (mild or severe), discontinuation of treatment (reason and date), event occurrence information (fatal myocardial infarction, coronary artery disease requiring PCI, cardiovascular death, hospitalization for heart failure, stroke (cerebral infarction, cerebral hemorrhage), all-cause mortality, initiation of renal replacement therapy, progression to eGFR <15 mL/min/1.73m2, progression to overt proteinuria)
6)Analysis by presence or absence of beta-blockers or chronic heart failure
7)Analysis by presence or absence of chronic kidney disease
8)Analysis by estimated daily salt intake
9)Analysis by age (65 years)
10)Analysis by presence or absence of diabetes
11)Analysis by Sacubitril/Valsartan dosage
12)Continuation of treatment beyond 12 weeks (final assessment includes treatment regimen and blood pressure values at 1 year, rate of blood pressure target achievement, and renal function)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sacubitril/Valsartan Group
Interventions/Control_2
Indapamido Group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been receiving combination therapy with an ARB and a CCB at or above the usual dose for at least 4 weeks prior to screening, without any changes in dosage
2) Patients who, at the start of the study, do not meet either of the following criteria: a target office blood pressure of <130/80 mmHg, or an average early-morning home blood pressure of <125/75 mmHg over the past week
3) Patients who, after receiving a thorough explanation regarding participation in this trial, provided written informed consent of their own free will based on full understanding
4) 18 years of age or older
Key exclusion criteria
1. Under 18 years of age
2. Patients who have received treatment with thiazide diuretics or Sacubitril/Valsartan within the past year
3. Patients with severe hypertension(persistent systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg).
4. Patients with clearly secondary hypertension due to underlying conditions such as primary aldosteronism, renovascular hypertension, or pheochromocytoma
5. Patients requiring renal replacement therapy or with severe renal impairment (eGFR<30 mL/min/1.73 m2)
6. Severe proteinuria at the nephrotic level (protein-to-creatinine ratio>3.5 g/gCr)
7. Severe hepatic impairment (e.g., cirrhosis, Child-Pugh Class C),
8.NYHA Class III or higher, poorly controlled severe chronic heart failure
9. End-stage malignant disease
10. Patients with severe infections
11. Pregnancy
12. Patients deemed unsuitable for enrollment by the attending physician due to poor adherence to medical visits or medication
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kyoji |
| Middle name | |
| Last name | Chiba |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Nephrology
Zip code
247-8581
Address
132 Katsura-cho, Sakae-ku, Yokohama City, Kanagawa
TEL
0458912171
kyoji.chiba@gmail.com
Public contact
Name of contact person
| 1st name | Kyoji |
| Middle name | |
| Last name | Chiba |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Nephrology
Zip code
2458581
Address
132 Katsura-cho, Sakae-ku, Yokohama City, Kanagawa
TEL
0458912171
Homepage URL
kyoji.chiba@gmail.com
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
kyoji chiba
Funding Source
Organization
self-funded
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
Yokohama Sakae Kyosai Hospital
Address
132 Katsura-cho, Sakae-ku, Yokohama City, Kanagawa
Tel
0458912171
kyoji.chiba@gmail.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
| 2026 | Year | 06 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070696
