JPRN-jRCT2031200432Active, not recruiting未知
Special drug use surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)
Sugimoto Toshiya0 sites660 target enrollmentStarted: March 18, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 660
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients must provide written consent to cooperate in this study before the start of Entresto
- •2. Patients using Entresto for the first time for the following indication
- •-Indication: chronic heart failure patients on standard of care for chronic heart failure
Exclusion Criteria
- •1. Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
- •2. The following patients for whom Entresto is contraindicated in the package insert
- •Patients with a history of hypersensitivity to any of the Entresto ingredients
- •Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.)
- •Diabetic patients on aliskiren fumarate
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •Pregnant or possibly pregnant women
Investigators
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