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Special Drug Use Surveillance of Entresto Tablets (Hypertension)

NCT ID: NCT05976230

Last Updated: 2025-07-03

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

COMPLETED

Total Enrollment

1125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-05-29

Brief Summary

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This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.

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Detailed Description

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This study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of Entresto Tablets in patients with hypertension in Japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Entresto

Patients administered Entresto by prescription

Entresto

Intervention Type DRUG

There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

Interventions

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Entresto

There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

Intervention Type DRUG

Other Intervention Names

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Entresto Tablets

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anjo, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Kasugai, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Ōbu, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Yatomi, Aichi-ken, Japan

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Inzai, Chiba, Japan

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Matsudo, Chiba, Japan

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Sakura, Chiba, Japan

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Yotsukaidō, Chiba, Japan

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Matsuyama, Ehime, Japan

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Matsuyama, Ehime, Japan

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Saijō, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kasuga, Fukuoka, Japan

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Kasuga, Fukuoka, Japan

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Kasuya Gun, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Nakagawa, Fukuoka, Japan

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Omuta, Fukuoka, Japan

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Yame, Fukuoka, Japan

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Hiroshima, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Takehara, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Amagasaki, Hyōgo, Japan

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Kasai, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Bandō, Ibaraki, Japan

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Chikusei, Ibaraki, Japan

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Koga, Ibaraki, Japan

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Moriya, Ibaraki, Japan

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Ryūgasaki, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Aiko-gun, Kanagawa, Japan

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Fujisawa, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Yamaga, Kumamoto, Japan

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Iki, Nagasaki, Japan

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Nagasaki, Nagasaki, Japan

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Nagasaki, Nagasaki, Japan

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Nakatsu, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Kurashiki, Okayama-ken, Japan

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Hirakata, Osaka, Japan

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Ikeda, Osaka, Japan

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Minoo, Osaka, Japan

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Moriguchi, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Suita, Osaka, Japan

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Takatsuki, Osaka, Japan

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Toyonaka, Osaka, Japan

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Kashima, Saga-ken, Japan

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Kishima-gun, Saga-ken, Japan

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Tosu, Saga-ken, Japan

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Ureshino, Saga-ken, Japan

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Asaka, Saitama, Japan

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Fujimino, Saitama, Japan

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Gyōda, Saitama, Japan

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Kawaguchi, Saitama, Japan

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Niiza, Saitama, Japan

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Saitama, Saitama, Japan

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Satte, Saitama, Japan

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Sayama, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Akishima, Tokyo, Japan

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Edogawa-ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Katsushika-ku, Tokyo, Japan

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Kokubunji, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Machida, Tokyo, Japan

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Machida, Tokyo, Japan

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Machida, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Takaoka, Toyama, Japan

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Shimonoseki, Yamaguchi, Japan

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Yamaguchi, Yamaguchi, Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Countries

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Japan

Other Identifiers

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CLCZ696A1402

Identifier Type: -

Identifier Source: org_study_id

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