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Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Novartis

Conditions:

Essential Hypertension

Eligibility:

All Genders

18+ years

Brief Summary

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...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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.
  • Exclusion criteria:
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 31 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2025

    Estimated Enrollment :

    1405 Patients enrolled

    Trial Details

    Trial ID

    NCT06604897

    Start Date

    January 31 2023

    End Date

    March 31 2025

    Last Update

    September 20 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Novartis

    East Hanover, New Jersey, United States, 07936