Essential HypertensionNCT06604897
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
An observational study of Essential Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey [JAMDAS]) owned by M3 Inc. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Essential Hypertension
- How many people
- 1,405 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective, noninterventional cohort study.
Who may be able to join
- Diagnosed with essential hypertension (International Classification of Diseases [ICD]-10 code: I10) on the index date.
- Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
- Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
- Patients whose BP data can be extracted on the index date.
- Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
- Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.
Who cannot join
- Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
- Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
- Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
- Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
- Patients with severe impaired liver functions with Child-Pugh classification C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey [JAMDAS]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.
- Conditions
- Essential Hypertension
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan Cohort | Adult patients with essential hypertension who were prescribed sacubitril/valsartan. | |
| Conventional Drug-control Cohort | Adult patients with essential hypertension who were prescribed angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Secondary outcomes (16)
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
BP categories:
- Grade I: 140-159/90-99 millimeters of mercury (mmHg)
- Grade II: 160-179/100-109 mmHg
- Grade III: 180/110 mmHg or greater
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Number of antihypertensive medicines taken before starting sacubitril/valsartan categories: 0, 1, 2, 3-4, and 5 or more.
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Antihypertensive drug classes include:
- Calcium channel blockers (CCB)
- Angiotensin-converting enzyme (ACE) inhibitors
- Angiotensin receptor blockers (ARBs)
- Diuretics
- Alpha and beta blockers
- Alpha-beta blockers
- Aldosterone blockers
- Renin inhibitors
- Compounding agents
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Patient characteristics include, but are not limited to, age, gender, body mass index (BMI), comorbidities, and combinations of comorbidities.
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Number of Patients Categorized by Place of Residence
Measured: Baseline
Height
Measured: Baseline
Weight
Measured: Baseline
Number of Patients Categorized by Comorbidities
Comorbidities include:
- Heart disease
- Diabetes
- Dyslipidemia
- Renal disease
- Cerebrovascular disease
- Other, specify
Measured: Baseline
Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Multivariate logistic regression analysis will be used to determine the association of the following variables in achieving the guideline-recommended BP.
- Age
- Gender
- Comorbidities
- Body mass index (BMI)
- BP category at index date
- Number of classes of antihypertensive medicines taken before starting sacubitril/valsartan
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Persistence on Sacubitril/Valsartan
Proportion of patients remaining on treatment with sacubitril/valsartan and proportion of patients permanently discontinuing sacubitril/valsartan during the study.
Measured: Up to 16 weeks
Number of Episodes of Hypotension-related Events
Hypotension-related events include:
- Orthostatic hypotension
- Postural hypotension
- Secondary orthostatic hypotension
- Hypertension due to the drugs
- Episodic hypotension
- Hypotension
- Vertigo
- Feeling dizzy
- Dizziness
- Sudden dizziness
- Syncope
Measured: Up to 16 weeks
Number of Episodes of Renal Events
Renal events include:
- Renal diseases
- Chronic kidney disease (CKD)
- Estimated glomerular filtration rate (eGFR) reduction of 40% or more
Measured: Up to 16 weeks
Number of Episodes of Dehydration-related Events
Dehydration-related events include:
- Dehydration
- Isotonic dehydration
Measured: Up to 16 weeks
Number of Episodes of Diuresis-related Events
Diuresis-related events include:
- Polyuria
- Idiopathic polyuria
- Frequent urination
- Nocturnal polyuria
- Nocturia
Measured: Up to 16 weeks
Number of Episodes of Edema or Angioedema-related Events
Edema or angioedema-related events include:
- Angioneurotic edema
- Quincke's edema
Measured: Up to 16 weeks
Percentage of Patients Treated With Sacubitril/Valsartan Achieving the Guideline-recommended BP Compared to the Percentage of Patients Treated With Angiotensin-converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEi/ARB)
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
Measured: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start31 Jan 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604897
- Sponsor's protocol ID
- CLCZ696AJP04
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
Publications
Katsuya T, Nakatsu F, Eguchi S, Nakamura Y, Matsukawa M, Iekushi K, Hiramitsu S. Impact of treatment strategies incorporating sacubitril/valsartan on achievement of guideline-recommended blood pressure targets and representative safety outcomes. Hypertens Res. 2026 Apr;49(4):1232-1244. doi: 10.1038/s41440-025-02537-w. Epub 2026 Jan 14.
PubMed 41530466
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records
- ClinicalTrials.gov ID
- NCT06604897
- Acronym / sponsor ID
- CLCZ696AJP04
- Conditions
- Essential Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,405 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey [JAMDAS]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan Cohort | – | –Adult patients with essential hypertension who were prescribed sacubitril/valsartan. |
| Conventional Drug-control Cohort | – | –Adult patients with essential hypertension who were prescribed angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB). |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective, noninterventional cohort study.
Key inclusion criteria (6 listed)
- Diagnosed with essential hypertension (International Classification of Diseases [ICD]-10 code: I10) on the index date.
- Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
- Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
- Patients whose BP data can be extracted on the index date.
- Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
Key exclusion criteria (5 listed)
- Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
- Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
- Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
- Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
- Patients with severe impaired liver functions with Child-Pugh classification C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
16 secondary outcomes
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Number of Patients Categorized by Place of Residence
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Number of Patients Categorized by Comorbidities
Time frame: Baseline
Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Persistence on Sacubitril/Valsartan
Time frame: Up to 16 weeks
Number of Episodes of Hypotension-related Events
Time frame: Up to 16 weeks
Number of Episodes of Renal Events
Time frame: Up to 16 weeks
Number of Episodes of Dehydration-related Events
Time frame: Up to 16 weeks
Number of Episodes of Diuresis-related Events
Time frame: Up to 16 weeks
Number of Episodes of Edema or Angioedema-related Events
Time frame: Up to 16 weeks
Percentage of Patients Treated With Sacubitril/Valsartan Achieving the Guideline-recommended BP Compared to the Percentage of Patients Treated With Angiotensin-converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEi/ARB)
Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 41530466Katsuya T, Nakatsu F, Eguchi S, Nakamura Y, Matsukawa M, Iekushi K, Hiramitsu S. Impact of treatment strategies incorporating sacubitril/valsartan on achievement of guideline-recommended blood pressure targets and representative safety outcomes. Hypertens Res. 2026 Apr;49(4):1232-1244. doi: 10.1038/s41440-025-02537-w. Epub 2026 Jan 14.
- Link to study resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) (time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.