Special Drug Use Surveillance of Entresto Tablets (Hypertension)

NCT05976230 | Completed

• 1 other identifier: CLCZ696A1402
• Study Type: observational
• Target: 1,125
• Locations: 1 country
• Sites: 117

Brief 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.

Conditions

Hypertension

Keywords

hypertension; Entresto; Entresto Tablets; actual clinical practice; Japan; sacubitril/valsartan; sacubitril valsartan sodium hydrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor

  Up to 52 weeks

• Odds ratio (OR) for each risk factor 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

  Up to 52 weeks

• Percentage of patients who achieved blood pressure control at each evaluation time point

  Up to 52 weeks

• Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point

  Up to 52 weeks

Study Arms (1)

Entresto

Patients administered Entresto by prescription

Drug: Entresto

Interventions

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.

Also known as: Entresto Tablets

Entresto

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japanese patients with hypertension using Entresto

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (117)

Novartis Investigative Site

Anjo, Aichi-ken, 444-1154, Japan

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Ichinomiya, Aichi-ken, 494-0001, Japan

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Kasugai, Aichi-ken, 487-0024, Japan

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Nagoya, Aichi-ken, 460-0004, Japan

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Okazaki, Aichi-ken, 444-0856, Japan

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Ōbu, Aichi-ken, 474-0044, Japan

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Toyohashi, Aichi-ken, 440-0836, Japan

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Yatomi, Aichi-ken, 498-0048, Japan

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Inzai, Chiba, 270-1334, Japan

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Matsudo, Chiba, 270-0034, Japan

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Sakura, Chiba, 285-8765, Japan

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Yotsukaidō, Chiba, 284-0027, Japan

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Matsuyama, Ehime, 790-0051, Japan

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Matsuyama, Ehime, 790-0932, Japan

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Saijō, Ehime, 799-1371, Japan

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Fukuoka, Fukuoka, 815-0033, Japan

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Fukuoka, Fukuoka, 815-0041, Japan

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Kasuga, Fukuoka, 816-0807, Japan

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Kasuga, Fukuoka, 816-0833, Japan

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Kasuya Gun, Fukuoka, 811-2202, Japan

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Kitakyushu, Fukuoka, 804-0081, Japan

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Kitakyushu, Fukuoka, 805-0019, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Nakagawa, Fukuoka, 811-1244, Japan

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Omuta, Fukuoka, 837-0916, Japan

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Yame, Fukuoka, 834-0004, Japan

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Hiroshima, Hiroshima, 731-0102, Japan

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Hiroshima, Hiroshima, 731-0154, Japan

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Hiroshima, Hiroshima, 731-0221, Japan

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Takehara, Hiroshima, 725-0026, Japan

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Sapporo, Hokkaido, 001-0017, Japan

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Sapporo, Hokkaido, 060-0031, Japan

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Sapporo, Hokkaido, 064-0802, Japan

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Sapporo, Hokkaido, 064-0809, Japan

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Akashi, Hyōgo, 673-0023, Japan

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Amagasaki, Hyōgo, 660-0861, Japan

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Kasai, Hyōgo, 679-0103, Japan

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Kobe, Hyōgo, 650-0047, Japan

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Kobe, Hyōgo, 651-1302, Japan

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Kobe, Hyōgo, 651-1505, Japan

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Kobe, Hyōgo, 651-2135, Japan

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Kobe, Hyōgo, 654-0121, Japan

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Nishinomiya, Hyōgo, 663-8107, Japan

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Bandō, Ibaraki, 306-0631, Japan

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Chikusei, Ibaraki, 309-1195, Japan

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Koga, Ibaraki, 306-0232, Japan

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Moriya, Ibaraki, 302-0118, Japan

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Ryūgasaki, Ibaraki, 301-0005, Japan

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Kanazawa, Ishikawa-ken, 920-0007, Japan

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Kagoshima, Kagoshima-ken, 892-0862, Japan

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Aiko-gun, Kanagawa, 243-0301, Japan

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Fujisawa, Kanagawa, 252-0804, Japan

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Yokohama, Kanagawa, 225-0013, Japan

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Yokohama, Kanagawa, 2260025, Japan

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Yokohama, Kanagawa, 2270046, Japan

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Yokohama, Kanagawa, 232-0052, Japan

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Yokohama, Kanagawa, 235-0045, Japan

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Yokohama, Kanagawa, 241-0821, Japan

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Yokosuka, Kanagawa, 238-0007, Japan

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Kumamoto, Kumamoto, 862-0924, Japan

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Yamaga, Kumamoto, 861-0382, Japan

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Iki, Nagasaki, 811-5135, Japan

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Nagasaki, Nagasaki, 852-8055, Japan

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Nagasaki, Nagasaki, 852-8511, Japan

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Nakatsu, Oita Prefecture, 871-0152, Japan

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Ōita, Oita Prefecture, 870-0837, Japan

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Kurashiki, Okayama-ken, 710-1101, Japan

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Kurashiki, Okayama-ken, 713-8121, Japan

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Hirakata, Osaka, 573-0058, Japan

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Ikeda, Osaka, 563-0047, Japan

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Minoo, Osaka, 562-0046, Japan

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Moriguchi, Osaka, 570-0012, Japan

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Moriguchi, Osaka, 570-8507, Japan

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Osaka, Osaka, 533-0013, Japan

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Osaka, Osaka, 534-0024, Japan

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Suita, Osaka, 565-0862, Japan

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Suita, Osaka, 565-0874, Japan

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Takatsuki, Osaka, 569-1121, Japan

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Toyonaka, Osaka, 561-0881, Japan

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Kashima, Saga-ken, 849-1311, Japan

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Kishima-gun, Saga-ken, 849-1203, Japan

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Tosu, Saga-ken, 841-0061, Japan

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Ureshino, Saga-ken, 843-0302, Japan

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Asaka, Saitama, 3510021, Japan

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Fujimino, Saitama, 356-0011, Japan

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Gyōda, Saitama, 361-0056, Japan

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Kawaguchi, Saitama, 333-0847, Japan

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Niiza, Saitama, 352-0023, Japan

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Saitama, Saitama, 339-0033, Japan

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Satte, Saitama, 340-0115, Japan

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Sayama, Saitama, 350-1305, Japan

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Tokorozawa, Saitama, 359-1106, Japan

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Tokorozawa, Saitama, 359-1141, Japan

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Akishima, Tokyo, 196-0015, Japan

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Edogawa-ku, Tokyo, 134-0081, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Katsushika-ku, Tokyo, 125-0042, Japan

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Kokubunji, Tokyo, 185-0011, Japan

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Koto-ku, Tokyo, 135-0003, Japan

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Machida, Tokyo, 194-0021, Japan

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Machida, Tokyo, 1940013, Japan

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Machida, Tokyo, 195-0074, Japan

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Mitaka, Tokyo, 181-0013, Japan

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Ōta-ku, Tokyo, 146-8531, Japan

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Setagaya-ku, Tokyo, 157-0066, Japan

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Shibuya City, Tokyo, 151-0053, Japan

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Toshima-ku, Tokyo, 171-0014, Japan

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Takaoka, Toyama, 939-1104, Japan

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Shimonoseki, Yamaguchi, 759-6301, Japan

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Yamaguchi, Yamaguchi, 754-0002, Japan

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Fukuoka, 810-0044, Japan

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Fukuoka, 810-0801, Japan

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Fukuoka, 812-0025, Japan

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Fukuoka, 812-0039, Japan

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Fukuoka, 814-0163, Japan

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Saitama, 3300074, Japan

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Saitama, 338-0837, Japan

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MeSH Terms

Conditions

Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: September 4, 2023
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (117)