Last Update: Apr 10, 2024
Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT
ClinicalTrials.gov Identifier:
NCT05976230
Novartis Reference Number:CLCZ696A1402
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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.

Hypertension
Recruiting
1000
Sep 04, 2023
Sep 30, 2025
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug

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.

Eligibility Criteria

Inclusion Criteria:

Patients who have given written consent to participate in this study before the start of treatment with Entresto
Patients who used Entresto for the first time for the indication of hypertension

Exclusion Criteria:

Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)

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
Patients with a history or complication of cardiac failure
Patients who have been hospitalized at the start of treatment with Entresto

Study Location

Novartis Investigative Site

Recruiting

Matsudo,Chiba,270-0034,Japan

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Setagaya-ku,Tokyo,157-0066,Japan

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Chikusei,Ibaraki,309-1195,Japan

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Nagoya,Aichi,461-0045,Japan

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Yamaga,Kumamoto,861-0382,Japan

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Kagoshima,892-0862,Japan

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Kobe-city,Hyogo,650-0047,Japan

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Saitama,338-0837,Japan

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Aiko-gun,Kanagawa,243-0301,Japan

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Moriya-city,Ibaraki,302-0102,Japan

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Tokorozawa,Saitama,359-1106,Japan

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Hirakata,Osaka,573-0058,Japan

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Yokohama,Kanagawa,241-0821,Japan

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Kasuya-gun,Fukuoka,811-2202,Japan

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Osaka,533-0013,Japan

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Matsuyama,Ehime,790-0051,Japan

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Suita,Osaka,565-0862,Japan

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Edogawa-ku,Tokyo,134-0081,Japan

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Nakagawa,Fukuoka,811-1244,Japan

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Yame,Fukuoka,834-0004,Japan

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Kanazawa,Ishikawa,920-0007,Japan

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Akashi,Hyogo,673-0023,Japan

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Kobe,Hyogo,651-1302,Japan

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Sakura,Chiba,285-8765,Japan

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Moriya,Ibaraki,302-0118,Japan

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Toshima-ku,Tokyo,170-0004,Japan

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Ichinomiya,Aichi,494-0001,Japan

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Osaka,534-0024,Japan

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Yokosuka,Kanagawa,238-0007,Japan

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Katsushika-ku,Tokyo,125-0042,Japan

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Fujimino,Saitama,356-0011,Japan

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Matsuyama,Ehime,790-0932,Japan

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Suita,Osaka,565-0874,Japan

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Nakatsu,Oita,871-0152,Japan

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Yokohama,Kanagawa,225-0013,Japan

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Kasai,Hyogo,679-0103,Japan

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Sapporo,Hokkaido,060-0031,Japan

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Amagasaki,Hyogo,660-0861,Japan

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Kumamoto,862-0924,Japan

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Ikeda,Osaka,563-0047,Japan

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Nagasaki-shi,Nagasaki,852-8511,Japan

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Toshima-ku,Tokyo,171-0014,Japan

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Ota,Tokyo,146-8531,Japan

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Yotsukaido,Chiba,284-0027,Japan

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Kishima-gun,Saga,849-1203,Japan

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Tachikawa,Tokyo,190-0023,Japan

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Fujisawa,Kanagawa,252-0804,Japan

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Minoo,Osaka,562-0046,Japan

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Niiza,Saitama,352-0023,Japan

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Yokohama,Kanagawa,2260025,Japan

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Kashima,Saga,849-1311,Japan

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Sapporo,Hokkaido,064-0809,Japan

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Anjo,Aichi,444-1154,Japan

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Kurashiki,Okayama,710-1101,Japan

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Tosu,Saga,841-0061,Japan

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Iki-city,Nagasaki,811-5135,Japan

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Nagasaki,851-2211,Japan

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Ryugasaki,Ibaraki,301-0005,Japan

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Kita-Katsuragi-gun,Nara,636-0002,Japan

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Takaoka,Toyama,939-1104,Japan

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Fukuoka,810-0801,Japan

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Mitaka,Tokyo,181-0013,Japan

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Yokohama,Kanagawa,227-0046,Japan

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Kasugai,Aichi,487-0024,Japan

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Obu,Aichi,474-0044,Japan

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Satte,Saitama,340-0115,Japan

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Atsugi,Kanagawa,243-0013,Japan

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Kurashiki,Okayama,713-8121,Japan

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Toyonaka,Osaka,561-0881,Japan

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Inzai,Chiba,270-1334,Japan

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Nagasaki,852-8055,Japan

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Kitakyushu,Fukuoka,804-0081,Japan

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Saijo,Ehime,799-1371,Japan

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Takatsuki,Osaka,569-1121,Japan

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Gyoda,Saitama,361-0056,Japan

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Moriguchi,Osaka,570-0012,Japan

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Yokohama,Kanagawa,232-0052,Japan

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Kasuga,Fukuoka,816-0807,Japan

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Omuta,Fukuoka,837-0916,Japan

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Kurume city,Fukuoka,830-0011,Japan

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Sayama,Saitama,350-1305,Japan

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Bunkyo-ku,Tokyo,113-0031,Japan

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Ureshino,Saga,843-0302,Japan

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Iruma,Saitama,358-0026,Japan

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Nagoya,Aichi,460-0004,Japan

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Kitakyushu,Fukuoka,805-0019,Japan

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Saitama,330-0074,Japan

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Moriguchi,Osaka,570-8507,Japan

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Takehara,Hiroshima,725-0026,Japan

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Hachioji-city,Tokyo,192-0918,Japan

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Yokohama,Kanagawa,235-0045,Japan

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Kasuga,Fukuoka,816-0833,Japan

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+81337978748