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Real-world safety check for entresto in japanese hypertension patients

NCT ID NCT05976230

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 1,100 Japanese adults with high blood pressure who are prescribed Entresto tablets. Researchers track side effects like low blood pressure, high potassium, and kidney issues over 52 weeks. The goal is to see how safe and effective Entresto is in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Entresto (sacubitril/valsartan)
What this could lead to
If successful, this study could confirm that Entresto is a safe and effective long-term option for managing high blood pressure in Japanese patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. Risks include low blood pressure, high potassium, and kidney problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,125 people

The number who actually took part.

Started

Sep 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Japanese patients with hypertension using Entresto

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who have given written consent to participate in this study before the start of treatment with Entresto 2. Patients who used Entresto for the first time for the indication of hypertension Exclusion Criteria: 1. Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug) 2. The following patients for whom administration of Entresto is contraindicated in the package insert: * Patients with a history of hypersensitivity to any of the ingredients of Entresto * Patients who are receiving angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril hydrate) or who discontinued these drugs within 36 hours. * Patients with a history of angioedema (angioedema due to angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.) * Patients with diabetes mellitus who are receiving aliskiren fumarate * Patients with severe hepatic impairment (Child-Pugh class C) * Pregnant or possibly pregnant women 3. Patients with a history or complication of cardiac failure 4. Patients who have been hospitalized at the start of treatment with Entresto

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

Contacts and locations

Locations

  • Novartis Investigative Site

    Anjo, Aichi-ken, 444-1154, Japan

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 494-0001, Japan

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 487-0024, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0004, Japan

  • Novartis Investigative Site

    Okazaki, Aichi-ken, 444-0856, Japan

  • Novartis Investigative Site

    Ōbu, Aichi-ken, 474-0044, Japan

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 440-0836, Japan

  • Novartis Investigative Site

    Yatomi, Aichi-ken, 498-0048, Japan

  • Novartis Investigative Site

    Inzai, Chiba, 270-1334, Japan

  • Novartis Investigative Site

    Matsudo, Chiba, 270-0034, Japan

  • Novartis Investigative Site

    Sakura, Chiba, 285-8765, Japan

  • Novartis Investigative Site

    Yotsukaidō, Chiba, 284-0027, Japan

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0051, Japan

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-0932, Japan

  • Novartis Investigative Site

    Saijō, Ehime, 799-1371, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 815-0033, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 815-0041, Japan

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0807, Japan

  • Novartis Investigative Site

    Kasuga, Fukuoka, 816-0833, Japan

  • Novartis Investigative Site

    Kasuya Gun, Fukuoka, 811-2202, Japan

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 804-0081, Japan

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 805-0019, Japan

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011, Japan

  • Novartis Investigative Site

    Nakagawa, Fukuoka, 811-1244, Japan

  • Novartis Investigative Site

    Omuta, Fukuoka, 837-0916, Japan

  • Novartis Investigative Site

    Yame, Fukuoka, 834-0004, Japan

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 731-0102, Japan

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 731-0154, Japan

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 731-0221, Japan

  • Novartis Investigative Site

    Takehara, Hiroshima, 725-0026, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 001-0017, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-0031, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 064-0802, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 064-0809, Japan

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-0023, Japan

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660-0861, Japan

  • Novartis Investigative Site

    Kasai, Hyōgo, 679-0103, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-1302, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-1505, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 651-2135, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 654-0121, Japan

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663-8107, Japan

  • Novartis Investigative Site

    Bandō, Ibaraki, 306-0631, Japan

  • Novartis Investigative Site

    Chikusei, Ibaraki, 309-1195, Japan

  • Novartis Investigative Site

    Koga, Ibaraki, 306-0232, Japan

  • Novartis Investigative Site

    Moriya, Ibaraki, 302-0118, Japan

  • Novartis Investigative Site

    Ryūgasaki, Ibaraki, 301-0005, Japan

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-0007, Japan

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 892-0862, Japan

  • Novartis Investigative Site

    Aiko-gun, Kanagawa, 243-0301, Japan

  • Novartis Investigative Site

    Fujisawa, Kanagawa, 252-0804, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 225-0013, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2260025, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2270046, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232-0052, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 235-0045, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-0821, Japan

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 238-0007, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 862-0924, Japan

  • Novartis Investigative Site

    Yamaga, Kumamoto, 861-0382, Japan

  • Novartis Investigative Site

    Iki, Nagasaki, 811-5135, Japan

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8055, Japan

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8511, Japan

  • Novartis Investigative Site

    Nakatsu, Oita Prefecture, 871-0152, Japan

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-0837, Japan

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-1101, Japan

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 713-8121, Japan

  • Novartis Investigative Site

    Hirakata, Osaka, 573-0058, Japan

  • Novartis Investigative Site

    Ikeda, Osaka, 563-0047, Japan

  • Novartis Investigative Site

    Minoo, Osaka, 562-0046, Japan

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-0012, Japan

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8507, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 533-0013, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 534-0024, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0862, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0874, Japan

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1121, Japan

  • Novartis Investigative Site

    Toyonaka, Osaka, 561-0881, Japan

  • Novartis Investigative Site

    Kashima, Saga-ken, 849-1311, Japan

  • Novartis Investigative Site

    Kishima-gun, Saga-ken, 849-1203, Japan

  • Novartis Investigative Site

    Tosu, Saga-ken, 841-0061, Japan

  • Novartis Investigative Site

    Ureshino, Saga-ken, 843-0302, Japan

  • Novartis Investigative Site

    Asaka, Saitama, 3510021, Japan

  • Novartis Investigative Site

    Fujimino, Saitama, 356-0011, Japan

  • Novartis Investigative Site

    Gyōda, Saitama, 361-0056, Japan

  • Novartis Investigative Site

    Kawaguchi, Saitama, 333-0847, Japan

  • Novartis Investigative Site

    Niiza, Saitama, 352-0023, Japan

  • Novartis Investigative Site

    Saitama, Saitama, 339-0033, Japan

  • Novartis Investigative Site

    Satte, Saitama, 340-0115, Japan

  • Novartis Investigative Site

    Sayama, Saitama, 350-1305, Japan

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1106, Japan

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1141, Japan

  • Novartis Investigative Site

    Akishima, Tokyo, 196-0015, Japan

  • Novartis Investigative Site

    Edogawa-ku, Tokyo, 134-0081, Japan

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0918, Japan

  • Novartis Investigative Site

    Katsushika-ku, Tokyo, 125-0042, Japan

  • Novartis Investigative Site

    Kokubunji, Tokyo, 185-0011, Japan

  • Novartis Investigative Site

    Koto-ku, Tokyo, 135-0003, Japan

  • Novartis Investigative Site

    Machida, Tokyo, 194-0021, Japan

  • Novartis Investigative Site

    Machida, Tokyo, 1940013, Japan

  • Novartis Investigative Site

    Machida, Tokyo, 195-0074, Japan

  • Novartis Investigative Site

    Mitaka, Tokyo, 181-0013, Japan

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 146-8531, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157-0066, Japan

  • Novartis Investigative Site

    Shibuya City, Tokyo, 151-0053, Japan

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0014, Japan

  • Novartis Investigative Site

    Takaoka, Toyama, 939-1104, Japan

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi, 759-6301, Japan

  • Novartis Investigative Site

    Yamaguchi, Yamaguchi, 754-0002, Japan

  • Novartis Investigative Site

    Fukuoka, 810-0044, Japan

  • Novartis Investigative Site

    Fukuoka, 810-0801, Japan

  • Novartis Investigative Site

    Fukuoka, 812-0025, Japan

  • Novartis Investigative Site

    Fukuoka, 812-0039, Japan

  • Novartis Investigative Site

    Fukuoka, 814-0163, Japan

  • Novartis Investigative Site

    Saitama, 3300074, Japan

  • Novartis Investigative Site

    Saitama, 338-0837, Japan

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