Special Drug Use Surveillance of Entresto Tablets (Hypertension)

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

Entresto

Clinical Study ID

NCT05976230
CLCZ696A1402
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have given written consent to participate in this study before thestart of treatment with Entresto

  2. Patients who used Entresto for the first time for the indication of hypertension

Exclusion

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 thepackage insert:

  • Patients with a history of hypersensitivity to any of the ingredients ofEntresto

  • 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 lisinoprilhydrate) or who discontinued these drugs within 36 hours.

  • Patients with a history of angioedema (angioedema due to angiotensin IIreceptor antagonists or angiotensin converting enzyme inhibitors, hereditaryangioedema, 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

  1. Patients with a history or complication of cardiac failure

  2. Patients who have been hospitalized at the start of treatment with Entresto

Study Design

Total Participants: 1125
Treatment Group(s): 1
Primary Treatment: Entresto
Phase:
Study Start date:
September 04, 2023
Estimated Completion Date:
September 30, 2025

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Anjo, Aichi 444-1154
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ichinomiya, Aichi 494-0001
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kasugai, Aichi 487-0024
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 460-0004
    Japan

    Site Not Available

  • Novartis Investigative Site

    Obu, Aichi 474-0044
    Japan

    Site Not Available

  • Novartis Investigative Site

    Okazaki, Aichi 444-0856
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyohashi, Aichi 440-0836
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yatomi, Aichi 498-0048
    Japan

    Site Not Available

  • Novartis Investigative Site

    Inzai, Chiba 270-1334
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsudo, Chiba 270-0034
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakura, Chiba 285-8765
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yotsukaido, Chiba 284-0027
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsuyama, Ehime 790-0051
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saijo, Ehime 799-1371
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kasuga, Fukuoka 816-0807
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kasuya Gun, Fukuoka 811-2202
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kasuya-gun, Fukuoka 811-2202
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kitakyushu, Fukuoka 805-0019
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kurume city, Fukuoka 830-0011
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nakagawa, Fukuoka 811-1244
    Japan

    Site Not Available

  • Novartis Investigative Site

    Omuta, Fukuoka 837-0916
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yame, Fukuoka 834-0004
    Japan

    Site Not Available

  • Novartis Investigative Site

    Takehara, Hiroshima 725-0026
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo, Hokkaido 064-0809
    Japan

    Site Not Available

  • Novartis Investigative Site

    Akashi, Hyogo 673-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Amagasaki, Hyogo 660-0861
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kasai, Hyogo 679-0103
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe, Hyogo 651-2135
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe-city, Hyogo 650-0047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nishinomiya, Hyogo 663-8107
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bando, Ibaraki 306-0631
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chikusei, Ibaraki 309-1195
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koga, Ibaraki 306-0232
    Japan

    Site Not Available

  • Novartis Investigative Site

    Moriya, Ibaraki 302-0118
    Japan

    Site Not Available

  • Novartis Investigative Site

    Moriya-city, Ibaraki 302-0102
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ryugasaki, Ibaraki 301-0005
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanazawa, Ishikawa 920-0007
    Japan

    Site Not Available

  • Novartis Investigative Site

    Aiko-gun, Kanagawa 243-0301
    Japan

    Site Not Available

  • Novartis Investigative Site

    Atsugi, Kanagawa 243-0013
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fujisawa, Kanagawa 252-0804
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara, Kanagawa 252-0236
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama, Kanagawa 241-0821
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokosuka, Kanagawa 238-0007
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yamaga, Kumamoto 861-0382
    Japan

    Site Not Available

  • Novartis Investigative Site

    Iki-city, Nagasaki 811-5135
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagasaki-shi, Nagasaki 852-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kita-Katsuragi-gun, Nara 636-0002
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nakatsu, Oita 871-0152
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kurashiki, Okayama 710-1101
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hirakata, Osaka 573-0058
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ikeda, Osaka 563-0047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Minoo, Osaka 562-0046
    Japan

    Site Not Available

  • Novartis Investigative Site

    Moriguchi, Osaka 570-8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita, Osaka 565-0874
    Japan

    Site Not Available

  • Novartis Investigative Site

    Takatsuki, Osaka 569-1121
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyonaka, Osaka 561-0881
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kashima, Saga 849-1311
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kishima-gun, Saga 849-1203
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tosu, Saga 841-0061
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ureshino, Saga 843-0302
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asaka, Saitama 3510021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fujimino, Saitama 356-0011
    Japan

    Site Not Available

  • Novartis Investigative Site

    Gyoda, Saitama 361-0056
    Japan

    Site Not Available

  • Novartis Investigative Site

    Iruma, Saitama 358-0026
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawaguchi, Saitama 333-0847
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kitamoto-city, Saitama 364-8501
    Japan

    Site Not Available

  • Novartis Investigative Site

    Niiza, Saitama 352-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Satte, Saitama 340-0115
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sayama, Saitama 350-1305
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tokorozawa, Saitama 359-1141
    Japan

    Site Not Available

  • Novartis Investigative Site

    Akishima, Tokyo 196-0015
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo 113-0031
    Japan

    Site Not Available

  • Novartis Investigative Site

    Edogawa-ku, Tokyo 134-0081
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji, Tokyo 192-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji-city, Tokyo 192-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Katsushika-ku, Tokyo 125-0042
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kokubunji, Tokyo 185-0011
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto-ku, Tokyo 135-0003
    Japan

    Site Not Available

  • Novartis Investigative Site

    Machida, Tokyo 194-0021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Mitaka, Tokyo 181-0013
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nerima-ku, Tokyo 178-0065
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ota, Tokyo 146-8531
    Japan

    Site Not Available

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-0066
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shibuya, Tokyo 151-0053
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tachikawa, Tokyo 190-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toshima-ku, Tokyo 171-0014
    Japan

    Site Not Available

  • Novartis Investigative Site

    Takaoka, Toyama 939-1104
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi 759-6301
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, 812-0025
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hiroshima, 731-0221
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kagoshima, 892-0862
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kumamoto, 862-0924
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagasaki, 852-8055
    Japan

    Site Not Available

  • Novartis Investigative Site

    Oita, 870-0837
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 533-0013
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saitama, 338-0837
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yamaguchi, 754-0002
    Japan

    Site Not Available

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