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Completed

NCT Number: NCT05976230

Special Drug Use Surveillance of Entresto Tablets (Hypertension)

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Anjo, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Entresto

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ENLIGHT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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