Last Update: Jun 14, 2024
Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLCZ696A1402
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:

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

Study Location

Novartis Investigative Site

Recruiting

Kitakyushu,Fukuoka,804-0081,Japan

Novartis Investigative Site

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Ureshino,Saga,843-0302,Japan

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Sayama,Saitama,350-1305,Japan

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Moriguchi,Osaka,570-0012,Japan

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Bunkyo-ku,Tokyo,113-0031,Japan

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Saitama,330-0074,Japan

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Kagoshima,892-0862,Japan

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Takehara,Hiroshima,725-0026,Japan

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Kurashiki,Okayama,713-8121,Japan

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Yokohama,Kanagawa,241-0821,Japan

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Setagaya-ku,Tokyo,157-0066,Japan

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Nakatsu,Oita,871-0152,Japan

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Hirakata,Osaka,573-0058,Japan

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Kitakyushu,Fukuoka,805-0019,Japan

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Yame,Fukuoka,834-0004,Japan

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Moriguchi,Osaka,570-8507,Japan

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Chikusei,Ibaraki,309-1195,Japan

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Tokorozawa,Saitama,359-1106,Japan

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Saitama,338-0837,Japan

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Kanazawa,Ishikawa,920-0007,Japan

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Kurume city,Fukuoka,830-0011,Japan

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Yokosuka,Kanagawa,238-0007,Japan

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Aiko-gun,Kanagawa,243-0301,Japan

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Suita,Osaka,565-0862,Japan

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Niiza,Saitama,352-0023,Japan

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Ichinomiya,Aichi,494-0001,Japan

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Yokohama,Kanagawa,225-0013,Japan

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Kitamoto-city,Saitama,364-8501,Japan

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Moriya-city,Ibaraki,302-0102,Japan

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Edogawa-ku,Tokyo,134-0081,Japan

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Toshima-ku,Tokyo,170-0004,Japan

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Sakura,Chiba,285-8765,Japan

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Kasai,Hyogo,679-0103,Japan

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Akashi,Hyogo,673-0023,Japan

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Matsudo,Chiba,270-0034,Japan

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Suita,Osaka,565-0874,Japan

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Omuta,Fukuoka,837-0916,Japan

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Ikeda,Osaka,563-0047,Japan

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Yokohama,Kanagawa,2260025,Japan

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Kobe,Hyogo,650-0047,Japan

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Fujimino,Saitama,356-0011,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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Sapporo,Hokkaido,001-0017,Japan

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Kasuga,Fukuoka,816-0833,Japan

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Amagasaki,Hyogo,660-0861,Japan

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Matsuyama,Ehime,790-0051,Japan

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Iki-city,Nagasaki,811-5135,Japan

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Tachikawa,Tokyo,190-0023,Japan

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Osaka,533-0013,Japan

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Yokohama,Kanagawa,227-0046,Japan

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Kobe,Hyogo,651-1302,Japan

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Fukuoka,810-0801,Japan

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Nagasaki,851-2211,Japan

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Kasuya-gun,Fukuoka,811-2202,Japan

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Tosu,Saga,841-0061,Japan

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Sapporo,Hokkaido,060-0031,Japan

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Anjo,Aichi,444-1154,Japan

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Minoo,Osaka,562-0046,Japan

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Inzai,Chiba,270-1334,Japan

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Takaoka,Toyama,939-1104,Japan

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Osaka,534-0024,Japan

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Kumamoto,862-0924,Japan

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Yokohama,Kanagawa,232-0052,Japan

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Gyoda,Saitama,361-0056,Japan

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Nagoya,Aichi,461-0045,Japan

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

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Toyonaka,Osaka,561-0881,Japan

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Satte,Saitama,340-0115,Japan

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Mitaka,Tokyo,181-0013,Japan

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Atsugi,Kanagawa,243-0013,Japan

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Iruma,Saitama,358-0026,Japan

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Takatsuki,Osaka,569-1121,Japan

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Ota,Tokyo,146-8531,Japan

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Kurashiki,Okayama,710-1101,Japan

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Yokohama,Kanagawa,235-0045,Japan

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Nakagawa,Fukuoka,811-1244,Japan

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Hachioji-city,Tokyo,192-0918,Japan

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