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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-03-31

Brief Summary

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This study is a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study will be 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.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sacubitril/Valsartan Cohort

Adult patients with essential hypertension who were prescribed sacubitril/valsartan.

No interventions assigned to this group

Conventional Drug-control Cohort

Adult patients with essential hypertension who were prescribed angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with essential hypertension (International Classification of Diseases \[ICD\]-10 code: I10) on the index date.
2. Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
3. Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
4. Patients whose BP data can be extracted on the index date.
5. Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
6. Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.

Exclusion Criteria

1. 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.
2. 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.
3. Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
4. Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
5. Patients with severe impaired liver functions with Child-Pugh classification C.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No