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

June 12, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1125

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals

Study Contact Backup

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
      • Saitama, Japan, 338-0837
        • Novartis Investigative Site
      • Saitama, Japan, 3300074
        • Novartis Investigative Site
    • Aichi-ken
      • Anjo, Aichi-ken, Japan, 444-1154
        • Novartis Investigative Site
      • Ichinomiya, Aichi-ken, Japan, 494-0001
        • Novartis Investigative Site
      • Kasugai, Aichi-ken, Japan, 487-0024
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 460-0004
        • Novartis Investigative Site
      • Okazaki, Aichi-ken, Japan, 444-0856
        • Novartis Investigative Site
      • Toyohashi, Aichi-ken, Japan, 440-0836
        • Novartis Investigative Site
      • Yatomi, Aichi-ken, Japan, 498-0048
        • Novartis Investigative Site
      • Ōbu, Aichi-ken, Japan, 474-0044
        • 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
      • Yotsukaidō, Chiba, Japan, 284-0027
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0932
        • Novartis Investigative Site
      • Matsuyama, Ehime, Japan, 790-0051
        • Novartis Investigative Site
      • Saijō, Ehime, Japan, 799-1371
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 815-0033
        • Novartis Investigative Site
      • Fukuoka, Fukuoka, Japan, 815-0041
        • Novartis Investigative Site
      • 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, 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
      • Hiroshima, Hiroshima, Japan, 731-0102
        • Novartis Investigative Site
      • Hiroshima, Hiroshima, Japan, 731-0154
        • Novartis Investigative Site
      • Hiroshima, Hiroshima, Japan, 731-0221
        • Novartis Investigative Site
      • 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
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-0023
        • Novartis Investigative Site
      • Amagasaki, Hyōgo, Japan, 660-0861
        • Novartis Investigative Site
      • Kasai, Hyōgo, Japan, 679-0103
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 650-0047
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 651-1302
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 651-1505
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 651-2135
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 654-0121
        • Novartis Investigative Site
      • Nishinomiya, Hyōgo, Japan, 663-8107
        • Novartis Investigative Site
    • Ibaraki
      • Bandō, 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
      • Ryūgasaki, Ibaraki, Japan, 301-0005
        • Novartis Investigative Site
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-0007
        • Novartis Investigative Site
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0862
        • 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
      • Kumamoto, Kumamoto, Japan, 862-0924
        • Novartis Investigative Site
      • Yamaga, Kumamoto, Japan, 861-0382
        • Novartis Investigative Site
    • Nagasaki
      • Iki, Nagasaki, Japan, 811-5135
        • Novartis Investigative Site
      • Nagasaki, Nagasaki, Japan, 852-8055
        • Novartis Investigative Site
      • Nagasaki, Nagasaki, Japan, 852-8511
        • Novartis Investigative Site
    • Oita Prefecture
      • Nakatsu, Oita Prefecture, Japan, 871-0152
        • Novartis Investigative Site
      • Ōita, Oita Prefecture, Japan, 870-0837
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 710-1101
        • Novartis Investigative Site
      • Kurashiki, Okayama-ken, 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
      • Osaka, Osaka, Japan, 533-0013
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 534-0024
        • 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-ken
      • Kashima, Saga-ken, Japan, 849-1311
        • Novartis Investigative Site
      • Kishima-gun, Saga-ken, Japan, 849-1203
        • Novartis Investigative Site
      • Tosu, Saga-ken, Japan, 841-0061
        • Novartis Investigative Site
      • Ureshino, Saga-ken, Japan, 843-0302
        • Novartis Investigative Site
    • Saitama
      • Asaka, Saitama, Japan, 3510021
        • Novartis Investigative Site
      • Fujimino, Saitama, Japan, 356-0011
        • Novartis Investigative Site
      • Gyōda, Saitama, Japan, 361-0056
        • Novartis Investigative Site
      • Kawaguchi, Saitama, Japan, 333-0847
        • Novartis Investigative Site
      • Niiza, Saitama, Japan, 352-0023
        • Novartis Investigative Site
      • Saitama, Saitama, Japan, 339-0033
        • 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
      • Hachiōji, 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
      • Setagaya-ku, Tokyo, Japan, 157-0066
        • Novartis Investigative Site
      • Shibuya City, Tokyo, Japan, 151-0053
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Novartis Investigative Site
      • Ōta-ku, Tokyo, Japan, 146-8531
        • Novartis Investigative Site
    • Toyama
      • Takaoka, Toyama, Japan, 939-1104
        • Novartis Investigative Site
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan, 759-6301
        • Novartis Investigative Site
      • Yamaguchi, Yamaguchi, Japan, 754-0002
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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