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

April 9, 2024 updated by: Novartis Pharmaceuticals

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Novartis Pharmaceuticals

Study Contact Backup

Study Locations

  • Japan
      • Fukuoka, Japan, 810-0044
        • Active, not recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 810-0801
        • Recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-0025
        • Active, not recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-0039
        • Active, not recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 813-0044
        • Withdrawn
        • Novartis Investigative Site
      • Fukuoka, Japan, 814-0163
        • Active, not recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 815-0033
        • Active, not recruiting
        • Novartis Investigative Site
      • Fukuoka, Japan, 815-0041
        • Active, not recruiting
        • Novartis Investigative Site
      • Hiroshima, Japan, 731-0102
        • Active, not recruiting
        • Novartis Investigative Site
      • Hiroshima, Japan, 731-0154
        • Active, not recruiting
        • Novartis Investigative Site
      • Hiroshima, Japan, 731-0221
        • Active, not recruiting
        • Novartis Investigative Site
      • Kagoshima, Japan, 892-0862
        • Recruiting
        • Novartis Investigative Site
      • Kumamoto, Japan, 862-0924
        • Recruiting
        • Novartis Investigative Site
      • Nagasaki, Japan, 852-8055
        • Recruiting
        • Novartis Investigative Site
      • Nagasaki, Japan, 851-2211
        • Recruiting
        • Novartis Investigative Site
      • Oita, Japan, 870-0837
        • Active, not recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 534-0024
        • Recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 533-0013
        • Recruiting
        • Novartis Investigative Site
      • Saitama, Japan, 330-0074
        • Recruiting
        • Novartis Investigative Site
      • Saitama, Japan, 338-0837
        • Recruiting
        • Novartis Investigative Site
      • Saitama, Japan, 339-0033
        • Active, not recruiting
        • Novartis Investigative Site
      • Yamaguchi, Japan, 754-0002
        • Active, not recruiting
        • Novartis Investigative Site
    • Aichi
      • Anjo, Aichi, Japan, 444-1154
        • Recruiting
        • Novartis Investigative Site
      • Ichinomiya, Aichi, Japan, 494-0001
        • Recruiting
        • Novartis Investigative Site
      • Kasugai, Aichi, Japan, 487-0024
        • Recruiting
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 460-0004
        • Recruiting
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 461-0045
        • Recruiting
        • Novartis Investigative Site
      • Obu, Aichi, Japan, 474-0044
        • Recruiting
        • Novartis Investigative Site
      • Okazaki, Aichi, Japan, 444-0856
        • Active, not recruiting
        • Novartis Investigative Site
      • Toyohashi, Aichi, Japan, 440-0836
        • Active, not recruiting
        • Novartis Investigative Site
      • Yatomi, Aichi, Japan, 498-0048
        • Active, not recruiting
        • Novartis Investigative Site
    • Chiba
      • Inzai, Chiba, Japan, 270-1334
        • Recruiting
        • Novartis Investigative Site
      • Matsudo, Chiba, Japan, 270-0034
        • Recruiting
        • Novartis Investigative Site
      • Sakura, Chiba, Japan, 285-8765
        • Recruiting
        • Novartis Investigative Site
      • Yotsukaido, Chiba, Japan, 284-0027
        • Recruiting
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0932
        • Recruiting
        • Novartis Investigative Site
      • Matsuyama, Ehime, Japan, 790-0051
        • Recruiting
        • Novartis Investigative Site
      • Saijo, Ehime, Japan, 799-1371
        • Recruiting
        • Novartis Investigative Site
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0807
        • Recruiting
        • Novartis Investigative Site
      • Kasuga, Fukuoka, Japan, 816-0833
        • Recruiting
        • Novartis Investigative Site
      • Kasuya-gun, Fukuoka, Japan, 811-2202
        • Recruiting
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 804-0081
        • Recruiting
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 805-0019
        • Recruiting
        • Novartis Investigative Site
      • Kurume city, Fukuoka, Japan, 830-0011
        • Recruiting
        • Novartis Investigative Site
      • Nakagawa, Fukuoka, Japan, 811-1244
        • Recruiting
        • Novartis Investigative Site
      • Omuta, Fukuoka, Japan, 837-0916
        • Recruiting
        • Novartis Investigative Site
      • Yame, Fukuoka, Japan, 834-0004
        • Recruiting
        • Novartis Investigative Site
    • Hiroshima
      • Takehara, Hiroshima, Japan, 725-0026
        • Recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0031
        • Recruiting
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 064-0809
        • Recruiting
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 004-0861
        • Withdrawn
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 064-0802
        • Active, not recruiting
        • Novartis Investigative Site
    • Hyogo
      • Akashi, Hyogo, Japan, 673-0023
        • Recruiting
        • Novartis Investigative Site
      • Amagasaki, Hyogo, Japan, 660-0861
        • Recruiting
        • Novartis Investigative Site
      • Kasai, Hyogo, Japan, 679-0103
        • Recruiting
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 651-1302
        • Recruiting
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 651-1505
        • Active, not recruiting
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 651-2135
        • Active, not recruiting
        • Novartis Investigative Site
      • Kobe, Hyogo, Japan, 654-0121
        • Active, not recruiting
        • Novartis Investigative Site
      • Kobe-city, Hyogo, Japan, 650-0047
        • Recruiting
        • Novartis Investigative Site
      • Nishinomiya, Hyogo, Japan, 663-8107
        • Active, not recruiting
        • Novartis Investigative Site
    • Ibaraki
      • Bando, Ibaraki, Japan, 306-0631
        • Active, not recruiting
        • Novartis Investigative Site
      • Chikusei, Ibaraki, Japan, 309-1195
        • Recruiting
        • Novartis Investigative Site
      • Koga, Ibaraki, Japan, 306-0232
        • Active, not recruiting
        • Novartis Investigative Site
      • Moriya, Ibaraki, Japan, 302-0118
        • Recruiting
        • Novartis Investigative Site
      • Moriya-city, Ibaraki, Japan, 302-0102
        • Recruiting
        • Novartis Investigative Site
      • Ryugasaki, Ibaraki, Japan, 301-0005
        • Recruiting
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-0007
        • Recruiting
        • Novartis Investigative Site
    • Kanagawa
      • Aiko-gun, Kanagawa, Japan, 243-0301
        • Recruiting
        • Novartis Investigative Site
      • Atsugi, Kanagawa, Japan, 243-0013
        • Recruiting
        • Novartis Investigative Site
      • Fujisawa, Kanagawa, Japan, 252-0804
        • Recruiting
        • Novartis Investigative Site
      • Sagamihara, Kanagawa, Japan, 252-0236
        • Withdrawn
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 241-0821
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 225-0013
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 227-0046
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 232-0052
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 235-0045
        • Recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 225-0013
        • Active, not recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 2260025
        • Recruiting
        • Novartis Investigative Site
      • Yokosuka, Kanagawa, Japan, 238-0007
        • Recruiting
        • Novartis Investigative Site
    • Kumamoto
      • Yamaga, Kumamoto, Japan, 861-0382
        • Recruiting
        • Novartis Investigative Site
    • Nagasaki
      • Iki-city, Nagasaki, Japan, 811-5135
        • Recruiting
        • Novartis Investigative Site
      • Nagasaki-shi, Nagasaki, Japan, 852-8511
        • Recruiting
        • Novartis Investigative Site
    • Nara
      • Kita-Katsuragi-gun, Nara, Japan, 636-0002
        • Recruiting
        • Novartis Investigative Site
    • Oita
      • Nakatsu, Oita, Japan, 871-0152
        • Recruiting
        • Novartis Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 710-1101
        • Recruiting
        • Novartis Investigative Site
      • Kurashiki, Okayama, Japan, 713-8121
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Hirakata, Osaka, Japan, 573-0058
        • Recruiting
        • Novartis Investigative Site
      • Hirakata, Osaka, Japan, 573-0022
        • Withdrawn
        • Novartis Investigative Site
      • Ikeda, Osaka, Japan, 563-0047
        • Recruiting
        • Novartis Investigative Site
      • Minoo, Osaka, Japan, 562-0046
        • Recruiting
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-8507
        • Recruiting
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-0012
        • Recruiting
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565-0874
        • Recruiting
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565-0862
        • Recruiting
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 569-1121
        • Recruiting
        • Novartis Investigative Site
      • Toyonaka, Osaka, Japan, 561-0881
        • Recruiting
        • Novartis Investigative Site
    • Saga
      • Kashima, Saga, Japan, 849-1311
        • Recruiting
        • Novartis Investigative Site
      • Kishima-gun, Saga, Japan, 849-1203
        • Recruiting
        • Novartis Investigative Site
      • Tosu, Saga, Japan, 841-0061
        • Recruiting
        • Novartis Investigative Site
      • Ureshino, Saga, Japan, 843-0302
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Asaka, Saitama, Japan, 351-0021
        • Active, not recruiting
        • Novartis Investigative Site
      • Fujimino, Saitama, Japan, 356-0011
        • Recruiting
        • Novartis Investigative Site
      • Gyoda, Saitama, Japan, 361-0056
        • Recruiting
        • Novartis Investigative Site
      • Iruma, Saitama, Japan, 358-0026
        • Recruiting
        • Novartis Investigative Site
      • Kawaguchi, Saitama, Japan, 333-0847
        • Active, not recruiting
        • Novartis Investigative Site
      • Niiza, Saitama, Japan, 352-0023
        • Recruiting
        • Novartis Investigative Site
      • Satte, Saitama, Japan, 340-0115
        • Recruiting
        • Novartis Investigative Site
      • Sayama, Saitama, Japan, 350-1305
        • Recruiting
        • Novartis Investigative Site
      • Tokorozawa, Saitama, Japan, 359-1106
        • Recruiting
        • Novartis Investigative Site
      • Tokorozawa, Saitama, Japan, 359-1141
        • Active, not recruiting
        • Novartis Investigative Site
    • Tokyo
      • Akishima, Tokyo, Japan, 196-0015
        • Active, not recruiting
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-0031
        • Recruiting
        • Novartis Investigative Site
      • Edogawa-ku, Tokyo, Japan, 134-0081
        • Recruiting
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japan, 192-0918
        • Recruiting
        • Novartis Investigative Site
      • Katsushika-ku, Tokyo, Japan, 125-0042
        • Recruiting
        • Novartis Investigative Site
      • Kokubunji, Tokyo, Japan, 185-0011
        • Active, not recruiting
        • Novartis Investigative Site
      • Koto-ku, Tokyo, Japan, 135-0003
        • Active, not recruiting
        • Novartis Investigative Site
      • Machida, Tokyo, Japan, 194-0013
        • Active, not recruiting
        • Novartis Investigative Site
      • Machida, Tokyo, Japan, 194-0021
        • Active, not recruiting
        • Novartis Investigative Site
      • Machida, Tokyo, Japan, 195-0074
        • Active, not recruiting
        • Novartis Investigative Site
      • Mitaka, Tokyo, Japan, 181-0013
        • Recruiting
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 178-0065
        • Withdrawn
        • Novartis Investigative Site
      • Ota, Tokyo, Japan, 146-8531
        • Recruiting
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, Japan, 157-0066
        • Recruiting
        • Novartis Investigative Site
      • Shibuya, Tokyo, Japan, 151-0053
        • Active, not recruiting
        • Novartis Investigative Site
      • Tachikawa, Tokyo, Japan, 190-0023
        • Recruiting
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 170-0004
        • Recruiting
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Recruiting
        • Novartis Investigative Site
    • Toyama
      • Takaoka, Toyama, Japan, 939-1104
        • Recruiting
        • Novartis Investigative Site
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 759-6301
        • Active, not recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Up to 52 weeks
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
Time Frame: Up to 52 weeks
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
Time Frame: Up to 52 weeks
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
Time Frame: Up to 52 weeks
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
Time Frame: Up to 52 weeks
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
Time Frame: Up to 52 weeks
To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 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)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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