Special Drug Use Surveillance of Entresto Tablets (Hypertension) (ENLIGHT)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Entresto

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.

• Study Type: Observational
• Enrollment (Actual): 1125

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 810-0044
    • Novartis Investigative Site
  • Fukuoka, Japan, 810-0801
    • Novartis Investigative Site
  • Fukuoka, Japan, 812-0025
    • Novartis Investigative Site
  • Fukuoka, Japan, 812-0039
    • Novartis Investigative Site
  • Fukuoka, Japan, 814-0163
    • Novartis Investigative Site
  • Fukuoka, Japan, 815-0033
    • Novartis Investigative Site
  • Fukuoka, Japan, 815-0041
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0102
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0154
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-0221
    • Novartis Investigative Site
  • Kagoshima, Japan, 892-0862
    • Novartis Investigative Site
  • Kumamoto, Japan, 862-0924
    • Novartis Investigative Site
  • Nagasaki, Japan, 852-8055
    • Novartis Investigative Site
  • Oita, Japan, 870-0837
    • Novartis Investigative Site
  • Osaka, Japan, 533-0013
    • Novartis Investigative Site
  • Osaka, Japan, 534-0024
    • Novartis Investigative Site
  • Saitama, Japan, 338-0837
    • Novartis Investigative Site
  • Saitama, Japan, 3300074
    • Novartis Investigative Site
  • Saitama, Japan, 339-0033
    • Novartis Investigative Site
  • Yamaguchi, Japan, 754-0002
    • Novartis Investigative Site
  • Aichi
    • Anjo, Aichi, Japan, 444-1154
      • Novartis Investigative Site
    • Ichinomiya, Aichi, Japan, 494-0001
      • Novartis Investigative Site
    • Kasugai, Aichi, Japan, 487-0024
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 460-0004
      • Novartis Investigative Site
    • Obu, Aichi, Japan, 474-0044
      • Novartis Investigative Site
    • Okazaki, Aichi, Japan, 444-0856
      • Novartis Investigative Site
    • Toyohashi, Aichi, Japan, 440-0836
      • Novartis Investigative Site
    • Yatomi, Aichi, Japan, 498-0048
      • Novartis Investigative Site
  • Chiba
    • Inzai, Chiba, Japan, 270-1334
      • Novartis Investigative Site
    • Matsudo, Chiba, Japan, 270-0034
      • Novartis Investigative Site
    • Sakura, Chiba, Japan, 285-8765
      • Novartis Investigative Site
    • Yotsukaido, Chiba, Japan, 284-0027
      • Novartis Investigative Site
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0932
      • Novartis Investigative Site
    • Matsuyama, Ehime, Japan, 790-0051
      • Novartis Investigative Site
    • Saijo, Ehime, Japan, 799-1371
      • Novartis Investigative Site
  • Fukuoka
    • Kasuga, Fukuoka, Japan, 816-0807
      • Novartis Investigative Site
    • Kasuga, Fukuoka, Japan, 816-0833
      • Novartis Investigative Site
    • Kasuya Gun, Fukuoka, Japan, 811-2202
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 804-0081
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 805-0019
      • Novartis Investigative Site
    • Kurume city, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
    • Nakagawa, Fukuoka, Japan, 811-1244
      • Novartis Investigative Site
    • Omuta, Fukuoka, Japan, 837-0916
      • Novartis Investigative Site
    • Yame, Fukuoka, Japan, 834-0004
      • Novartis Investigative Site
  • Hiroshima
    • Takehara, Hiroshima, Japan, 725-0026
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 001-0017
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 060-0031
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 064-0802
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 064-0809
      • Novartis Investigative Site
  • Hyogo
    • Akashi, Hyogo, Japan, 673-0023
      • Novartis Investigative Site
    • Amagasaki, Hyogo, Japan, 660-0861
      • Novartis Investigative Site
    • Kasai, Hyogo, Japan, 679-0103
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 650-0047
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 654-0121
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 651-1302
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 651-1505
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 651-2135
      • Novartis Investigative Site
    • Nishinomiya, Hyogo, Japan, 663-8107
      • Novartis Investigative Site
  • Ibaraki
    • Bando, Ibaraki, Japan, 306-0631
      • Novartis Investigative Site
    • Chikusei, Ibaraki, Japan, 309-1195
      • Novartis Investigative Site
    • Koga, Ibaraki, Japan, 306-0232
      • Novartis Investigative Site
    • Moriya, Ibaraki, Japan, 302-0118
      • Novartis Investigative Site
    • Ryugasaki, Ibaraki, Japan, 301-0005
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-0007
      • Novartis Investigative Site
  • Kanagawa
    • Aiko-gun, Kanagawa, Japan, 243-0301
      • Novartis Investigative Site
    • Fujisawa, Kanagawa, Japan, 252-0804
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 225-0013
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 2260025
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 2270046
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 232-0052
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 235-0045
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 241-0821
      • Novartis Investigative Site
    • Yokosuka, Kanagawa, Japan, 238-0007
      • Novartis Investigative Site
  • Kumamoto
    • Yamaga, Kumamoto, Japan, 861-0382
      • Novartis Investigative Site
  • Nagasaki
    • Iki-city, Nagasaki, Japan, 811-5135
      • Novartis Investigative Site
    • Nagasaki-shi, Nagasaki, Japan, 852-8511
      • Novartis Investigative Site
  • Oita
    • Nakatsu, Oita, Japan, 871-0152
      • Novartis Investigative Site
  • Okayama
    • Kurashiki, Okayama, Japan, 710-1101
      • Novartis Investigative Site
    • Kurashiki, Okayama, Japan, 713-8121
      • Novartis Investigative Site
  • Osaka
    • Hirakata, Osaka, Japan, 573-0058
      • Novartis Investigative Site
    • Ikeda, Osaka, Japan, 563-0047
      • Novartis Investigative Site
    • Minoo, Osaka, Japan, 562-0046
      • Novartis Investigative Site
    • Moriguchi, Osaka, Japan, 570-8507
      • Novartis Investigative Site
    • Moriguchi, Osaka, Japan, 570-0012
      • Novartis Investigative Site
    • Suita, Osaka, Japan, 565-0862
      • Novartis Investigative Site
    • Suita, Osaka, Japan, 565-0874
      • Novartis Investigative Site
    • Takatsuki, Osaka, Japan, 569-1121
      • Novartis Investigative Site
    • Toyonaka, Osaka, Japan, 561-0881
      • Novartis Investigative Site
  • Saga
    • Kashima, Saga, Japan, 849-1311
      • Novartis Investigative Site
    • Kishima-gun, Saga, Japan, 849-1203
      • Novartis Investigative Site
    • Tosu, Saga, Japan, 841-0061
      • Novartis Investigative Site
    • Ureshino, Saga, Japan, 843-0302
      • Novartis Investigative Site
  • Saitama
    • Asaka, Saitama, Japan, 3510021
      • Novartis Investigative Site
    • Fujimino, Saitama, Japan, 356-0011
      • Novartis Investigative Site
    • Gyoda, Saitama, Japan, 361-0056
      • Novartis Investigative Site
    • Kawaguchi, Saitama, Japan, 333-0847
      • Novartis Investigative Site
    • Niiza, Saitama, Japan, 352-0023
      • Novartis Investigative Site
    • Satte, Saitama, Japan, 340-0115
      • Novartis Investigative Site
    • Sayama, Saitama, Japan, 350-1305
      • Novartis Investigative Site
    • Tokorozawa, Saitama, Japan, 359-1106
      • Novartis Investigative Site
    • Tokorozawa, Saitama, Japan, 359-1141
      • Novartis Investigative Site
  • Tokyo
    • Akishima, Tokyo, Japan, 196-0015
      • Novartis Investigative Site
    • Edogawa-ku, Tokyo, Japan, 134-0081
      • Novartis Investigative Site
    • Hachioji, Tokyo, Japan, 192-0918
      • Novartis Investigative Site
    • Katsushika-ku, Tokyo, Japan, 125-0042
      • Novartis Investigative Site
    • Kokubunji, Tokyo, Japan, 185-0011
      • Novartis Investigative Site
    • Koto-ku, Tokyo, Japan, 135-0003
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 195-0074
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 194-0021
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 1940013
      • Novartis Investigative Site
    • Mitaka, Tokyo, Japan, 181-0013
      • Novartis Investigative Site
    • Ota, Tokyo, Japan, 146-8531
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 157-0066
      • Novartis Investigative Site
    • Shibuya, Tokyo, Japan, 151-0053
      • Novartis Investigative Site
    • Toshima-ku, Tokyo, Japan, 171-0014
      • Novartis Investigative Site
  • Toyama
    • Takaoka, Toyama, Japan, 939-1104
      • Novartis Investigative Site
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan, 759-6301
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Japanese patients with hypertension using Entresto

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Entresto; Patients administered Entresto by prescription	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.; Other Names: Entresto Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; Japan; sacubitril/valsartan; Entresto; sacubitril valsartan sodium hydrate; Entresto Tablets; actual clinical practice
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Angiotensin Receptor Antagonists; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696A1402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No