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NCT05976230 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 4, 2023
Est. completion date September 30, 2025

Study information
Verified date June 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone +81337978748
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
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

Study Design

Related Conditions & MeSH terms

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 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 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
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