Special Drug Use Surveillance of Entresto Tablets (Hypertension)

Hypertension Clinical Trial

— ENLIGHT  

Official title:

Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976230
• Other study ID #: CLCZ696A1402
• Status: Recruiting
• Start date: September 4, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +81337978748
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Aiko-gun	Kanagawa
Japan	Novartis Investigative Site	Akashi	Hyogo
Japan	Novartis Investigative Site	Akishima	Tokyo
Japan	Novartis Investigative Site	Amagasaki	Hyogo
Japan	Novartis Investigative Site	Anjo	Aichi
Japan	Novartis Investigative Site	Asaka	Saitama
Japan	Novartis Investigative Site	Atsugi	Kanagawa
Japan	Novartis Investigative Site	Bando	Ibaraki
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chikusei	Ibaraki
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Fujimino	Saitama
Japan	Novartis Investigative Site	Fujisawa	Kanagawa
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Gyoda	Saitama
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hirakata	Osaka
Japan	Novartis Investigative Site	Hirakata	Osaka
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Ichinomiya	Aichi
Japan	Novartis Investigative Site	Ikeda	Osaka
Japan	Novartis Investigative Site	Iki-city	Nagasaki
Japan	Novartis Investigative Site	Inzai	Chiba
Japan	Novartis Investigative Site	Iruma	Saitama
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kasai	Hyogo
Japan	Novartis Investigative Site	Kashima	Saga
Japan	Novartis Investigative Site	Kasuga	Fukuoka
Japan	Novartis Investigative Site	Kasuga	Fukuoka
Japan	Novartis Investigative Site	Kasugai	Aichi
Japan	Novartis Investigative Site	Kasuya-gun	Fukuoka
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kawaguchi	Saitama
Japan	Novartis Investigative Site	Kishima-gun	Saga
Japan	Novartis Investigative Site	Kita-Katsuragi-gun	Nara
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kitamoto-city	Saitama
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Koga	Ibaraki
Japan	Novartis Investigative Site	Kokubunji	Tokyo
Japan	Novartis Investigative Site	Koto-ku	Tokyo
Japan	Novartis Investigative Site	Kumamoto
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Kurume city	Fukuoka
Japan	Novartis Investigative Site	Machida	Tokyo
Japan	Novartis Investigative Site	Machida	Tokyo
Japan	Novartis Investigative Site	Machida	Tokyo
Japan	Novartis Investigative Site	Matsudo	Chiba
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Minoo	Osaka
Japan	Novartis Investigative Site	Mitaka	Tokyo
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Moriya	Ibaraki
Japan	Novartis Investigative Site	Moriya-city	Ibaraki
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-shi	Nagasaki
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nakagawa	Fukuoka
Japan	Novartis Investigative Site	Nakatsu	Oita
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Niiza	Saitama
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Obu	Aichi
Japan	Novartis Investigative Site	Oita
Japan	Novartis Investigative Site	Okazaki	Aichi
Japan	Novartis Investigative Site	Omuta	Fukuoka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Ota	Tokyo
Japan	Novartis Investigative Site	Ryugasaki	Ibaraki
Japan	Novartis Investigative Site	Sagamihara	Kanagawa
Japan	Novartis Investigative Site	Saijo	Ehime
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakura	Chiba
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Satte	Saitama
Japan	Novartis Investigative Site	Sayama	Saitama
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Japan	Novartis Investigative Site	Shibuya	Tokyo
Japan	Novartis Investigative Site	Shimonoseki	Yamaguchi
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Tachikawa	Tokyo
Japan	Novartis Investigative Site	Takaoka	Toyama
Japan	Novartis Investigative Site	Takatsuki	Osaka
Japan	Novartis Investigative Site	Takehara	Hiroshima
Japan	Novartis Investigative Site	Tokorozawa	Saitama
Japan	Novartis Investigative Site	Tokorozawa	Saitama
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Tosu	Saga
Japan	Novartis Investigative Site	Toyohashi	Aichi
Japan	Novartis Investigative Site	Toyonaka	Osaka
Japan	Novartis Investigative Site	Ureshino	Saga
Japan	Novartis Investigative Site	Yamaga	Kumamoto
Japan	Novartis Investigative Site	Yamaguchi
Japan	Novartis Investigative Site	Yame	Fukuoka
Japan	Novartis Investigative Site	Yatomi	Aichi
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yokosuka	Kanagawa
Japan	Novartis Investigative Site	Yotsukaido	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure	To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure	Up to 52 weeks
Secondary	Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor	To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure	Up to 52 weeks
Secondary	Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure	To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure	Up to 52 weeks
Secondary	Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time	To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting	Up to 52 weeks
Secondary	Percentage of patients who achieved blood pressure control at each evaluation time point	To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting	Up to 52 weeks
Secondary	Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point	To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting	Up to 52 weeks