Clinical trial NCT05976230: Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Official title: Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertension
Keywords: hypertension
Entresto
Entresto Tablets
actual clinical practice
Japan
sacubitril/valsartan
sacubitril valsartan sodium hydrate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 1125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese patients with hypertension using Entresto

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor
timeFrame: Up to 52 weeks
measure: Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure
timeFrame: Up to 52 weeks
measure: Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time
timeFrame: Up to 52 weeks
measure: Percentage of patients who achieved blood pressure control at each evaluation time point
timeFrame: Up to 52 weeks
measure: Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kasugai
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Obu
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Okazaki
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Yatomi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Inzai
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsudo
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Sakura
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yotsukaido
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Saijo
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Kasuga
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kasuga
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kasuya Gun
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Nakagawa
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Omuta
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yame
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Takehara
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kasai
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Bando
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Chikusei
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Koga
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Moriya
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Ryugasaki
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Aiko-gun
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Fujisawa
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yamaga
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Iki-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Nakatsu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Hirakata
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ikeda
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Minoo
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kashima
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Kishima-gun
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Tosu
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Ureshino
country: Japan
facility: Novartis Investigative Site
state: Saga
city: Asaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Fujimino
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Gyoda
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawaguchi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Niiza
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Satte
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Sayama
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Akishima
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kokubunji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Mitaka
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Takaoka
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Shimonoseki
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
city: Yamaguchi
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: