Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

NCT06604897 | Completed

• 1 other identifier: CLCZ696AJP04
• Study Type: observational
• Target: 1,405
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline

Study Arms (2)

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).

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• 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.

  PMID: 41530466 DERIVED

Related Links

• Link to study results

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 20, 2024
• Study Start: January 31, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

US (1)