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Special Drug Use Surveillance of Entresto Tablets (Hypertension)

CompletedN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Hypertension

Interventions: Entresto

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (117)

Anjo, Aichi-ken, Japan
Ichinomiya, Aichi-ken, Japan
Kasugai, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Ōbu, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Yatomi, Aichi-ken, Japan
Inzai, Chiba, Japan
Matsudo, Chiba, Japan
Sakura, Chiba, Japan
Yotsukaidō, Chiba, Japan
Matsuyama, Ehime, Japan
Matsuyama, Ehime, Japan
Saijō, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kasuya Gun, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Nakagawa, Fukuoka, Japan
Omuta, Fukuoka, Japan
Yame, Fukuoka, Japan
Hiroshima, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Takehara, Hiroshima, Japan
+ 87 more on CT.gov