HypertensionENLIGHTNCT05976230
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
An observational study of Hypertension, run by Novartis Pharmaceuticals at 117 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Entresto
- Type of treatment
- Pill or oral medicine
- How many people
- 1,125 participants
- Where
- 117 sitesJapan
- Study dates
- 4 Sep 2023to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Japanese patients with hypertension using Entresto
Who may be able to join
- Patients who have given written consent to participate in this study before the start of treatment with Entresto
- Patients who used Entresto for the first time for the indication of hypertension
Who cannot join
- Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)
- 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
Show all 10Show fewer
- Patients with severe hepatic impairment (Child-Pugh class C)
- Pregnant or possibly pregnant women
- Patients with a history or complication of cardiac failure
- Patients who have been hospitalized at the start of treatment with Entresto
Trial locations and contacts
117 sites in 1 country.
117 sites in 1 country
Japan117 sites
Novartis Investigative Site
Aiko-gun, Kanagawa, 243-0301
Novartis Investigative Site
Akashi, Hyōgo, 673-0023
Novartis Investigative Site
Akishima, Tokyo, 196-0015
Novartis Investigative Site
Amagasaki, Hyōgo, 660-0861
Novartis Investigative Site
Anjo, Aichi-ken, 444-1154
Novartis Investigative Site
Asaka, Saitama, 3510021
Novartis Investigative Site
Bandō, Ibaraki, 306-0631
Novartis Investigative Site
Chikusei, Ibaraki, 309-1195
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0081
Novartis Investigative Site
Fujimino, Saitama, 356-0011
Novartis Investigative Site
Fujisawa, Kanagawa, 252-0804
Novartis Investigative Site
Fukuoka, Fukuoka, 815-0033
Novartis Investigative Site
Fukuoka, Fukuoka, 815-0041
Novartis Investigative Site
Fukuoka, 810-0044
Novartis Investigative Site
Fukuoka, 810-0801
Novartis Investigative Site
Fukuoka, 812-0025
Novartis Investigative Site
Fukuoka, 812-0039
Novartis Investigative Site
Fukuoka, 814-0163
Novartis Investigative Site
Gyōda, Saitama, 361-0056
Novartis Investigative Site
Hachiōji, Tokyo, 192-0918
Novartis Investigative Site
Hirakata, Osaka, 573-0058
Novartis Investigative Site
Hiroshima, Hiroshima, 731-0102
Novartis Investigative Site
Hiroshima, Hiroshima, 731-0154
Novartis Investigative Site
Hiroshima, Hiroshima, 731-0221
Novartis Investigative Site
Ichinomiya, Aichi-ken, 494-0001
Novartis Investigative Site
Ikeda, Osaka, 563-0047
Novartis Investigative Site
Iki, Nagasaki, 811-5135
Novartis Investigative Site
Inzai, Chiba, 270-1334
Novartis Investigative Site
Kagoshima, Kagoshima-ken, 892-0862
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920-0007
Novartis Investigative Site
Kasai, Hyōgo, 679-0103
Novartis Investigative Site
Kashima, Saga-ken, 849-1311
Novartis Investigative Site
Kasuga, Fukuoka, 816-0807
Novartis Investigative Site
Kasuga, Fukuoka, 816-0833
Novartis Investigative Site
Kasugai, Aichi-ken, 487-0024
Novartis Investigative Site
Kasuya Gun, Fukuoka, 811-2202
Novartis Investigative Site
Katsushika-ku, Tokyo, 125-0042
Novartis Investigative Site
Kawaguchi, Saitama, 333-0847
Novartis Investigative Site
Kishima-gun, Saga-ken, 849-1203
Novartis Investigative Site
Kitakyushu, Fukuoka, 804-0081
Novartis Investigative Site
Kitakyushu, Fukuoka, 805-0019
Novartis Investigative Site
Kobe, Hyōgo, 650-0047
Novartis Investigative Site
Kobe, Hyōgo, 651-1302
Novartis Investigative Site
Kobe, Hyōgo, 651-1505
Novartis Investigative Site
Kobe, Hyōgo, 651-2135
Novartis Investigative Site
Kobe, Hyōgo, 654-0121
Novartis Investigative Site
Koga, Ibaraki, 306-0232
Novartis Investigative Site
Kokubunji, Tokyo, 185-0011
Novartis Investigative Site
Koto-ku, Tokyo, 135-0003
Novartis Investigative Site
Kumamoto, Kumamoto, 862-0924
Novartis Investigative Site
Kurashiki, Okayama-ken, 710-1101
Novartis Investigative Site
Kurashiki, Okayama-ken, 713-8121
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
Novartis Investigative Site
Machida, Tokyo, 194-0021
Novartis Investigative Site
Machida, Tokyo, 1940013
Novartis Investigative Site
Machida, Tokyo, 195-0074
Novartis Investigative Site
Matsudo, Chiba, 270-0034
Novartis Investigative Site
Matsuyama, Ehime, 790-0051
Novartis Investigative Site
Matsuyama, Ehime, 790-0932
Novartis Investigative Site
Minoh, Osaka, 562-0046
Novartis Investigative Site
Mitaka, Tokyo, 181-0013
Novartis Investigative Site
Moriguchi, Osaka, 570-0012
Novartis Investigative Site
Moriguchi, Osaka, 570-8507
Novartis Investigative Site
Moriya, Ibaraki, 302-0118
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8055
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8511
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0004
Novartis Investigative Site
Nakagawa, Fukuoka, 811-1244
Novartis Investigative Site
Nakatsu, Oita Prefecture, 871-0152
Novartis Investigative Site
Niiza, Saitama, 352-0023
Novartis Investigative Site
Nishinomiya, Hyōgo, 663-8107
Novartis Investigative Site
Ōbu, Aichi-ken, 474-0044
Novartis Investigative Site
Ōita, Oita Prefecture, 870-0837
Novartis Investigative Site
Okazaki, Aichi-ken, 444-0856
Novartis Investigative Site
Omuta, Fukuoka, 837-0916
Novartis Investigative Site
Osaka, Osaka, 533-0013
Novartis Investigative Site
Osaka, Osaka, 534-0024
Novartis Investigative Site
Ōta-ku, Tokyo, 146-8531
Novartis Investigative Site
Ryūgasaki, Ibaraki, 301-0005
Novartis Investigative Site
Saijō, Ehime, 799-1371
Novartis Investigative Site
Saitama, Saitama, 339-0033
Novartis Investigative Site
Saitama, 3300074
Novartis Investigative Site
Saitama, 338-0837
Novartis Investigative Site
Sakura, Chiba, 285-8765
Novartis Investigative Site
Sapporo, Hokkaido, 001-0017
Novartis Investigative Site
Sapporo, Hokkaido, 060-0031
Novartis Investigative Site
Sapporo, Hokkaido, 064-0802
Novartis Investigative Site
Sapporo, Hokkaido, 064-0809
Novartis Investigative Site
Satte, Saitama, 340-0115
Novartis Investigative Site
Sayama, Saitama, 350-1305
Novartis Investigative Site
Setagaya-ku, Tokyo, 157-0066
Novartis Investigative Site
Shibuya City, Tokyo, 151-0053
Novartis Investigative Site
Shimonoseki, Yamaguchi, 759-6301
Novartis Investigative Site
Suita, Osaka, 565-0862
Novartis Investigative Site
Suita, Osaka, 565-0874
Novartis Investigative Site
Takaoka, Toyama, 939-1104
Novartis Investigative Site
Takatsuki, Osaka, 569-1121
Novartis Investigative Site
Takehara, Hiroshima, 725-0026
Novartis Investigative Site
Tokorozawa, Saitama, 359-1106
Novartis Investigative Site
Tokorozawa, Saitama, 359-1141
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0014
Novartis Investigative Site
Tosu, Saga-ken, 841-0061
Novartis Investigative Site
Toyohashi, Aichi-ken, 440-0836
Novartis Investigative Site
Toyonaka, Osaka, 561-0881
Novartis Investigative Site
Ureshino, Saga-ken, 843-0302
Novartis Investigative Site
Yamaga, Kumamoto, 861-0382
Novartis Investigative Site
Yamaguchi, Yamaguchi, 754-0002
Novartis Investigative Site
Yame, Fukuoka, 834-0004
Novartis Investigative Site
Yatomi, Aichi-ken, 498-0048
Novartis Investigative Site
Yokohama, Kanagawa, 225-0013
Novartis Investigative Site
Yokohama, Kanagawa, 2260025
Novartis Investigative Site
Yokohama, Kanagawa, 2270046
Novartis Investigative Site
Yokohama, Kanagawa, 232-0052
Novartis Investigative Site
Yokohama, Kanagawa, 235-0045
Novartis Investigative Site
Yokohama, Kanagawa, 241-0821
Novartis Investigative Site
Yokosuka, Kanagawa, 238-0007
Novartis Investigative Site
Yotsukaidō, Chiba, 284-0027
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Entresto
- Keywords
- hypertension, Entresto, Entresto Tablets, actual clinical practice, Japan, sacubitril/valsartan, sacubitril valsartan sodium hydrate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrestoDrug
Also called Entresto Tablets
There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Entresto | Patients administered Entresto by prescription Receives: Drug: Entresto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 52 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start4 Sep 2023
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976230
- Sponsor's protocol ID
- CLCZ696A1402
- Acronym
- ENLIGHT
- Status last verified
- Jun 2025
- First submitted
- 28 Jul 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT
- ClinicalTrials.gov ID
- NCT05976230
- Acronym / sponsor ID
- ENLIGHT / CLCZ696A1402
- Conditions
- Hypertension
- Keywords
- hypertension, Entresto, Entresto Tablets, actual clinical practice, Japan, sacubitril/valsartan, sacubitril valsartan sodium hydrate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entresto | – | Drug: EntrestoPatients administered Entresto by prescription |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese patients with hypertension using Entresto
Key inclusion criteria (2 listed)
- Patients who have given written consent to participate in this study before the start of treatment with Entresto
- Patients who used Entresto for the first time for the indication of hypertension
Key exclusion criteria (10 listed)
- Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)
- The following patients for whom administration of Entresto is contraindicated in the package insert:
- Patients with a history or complication of cardiac failure
- Patients who have been hospitalized at the start of treatment with Entresto
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntrestoAlso: Entresto TabletsThere is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Entresto |
Primary outcome
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
5 secondary outcomes
Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor
Time frame: Up to 52 weeks
Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure
Time frame: 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
Percentage of patients who achieved blood pressure control at each evaluation time point
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
117 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Novartis Pharmaceuticals at 117 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 117 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.