Status:
COMPLETED
Special Drug Use Surveillance for Entresto Tablets
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
Up to 99 years
Brief Summary
This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
Detailed Description
This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved in...
Eligibility Criteria
Inclusion
- Patients must provide written consent to cooperate in this study before the start of Entresto
- 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
- Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
- 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
Key Trial Info
Start Date :
March 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT04781881
Start Date
March 4 2021
End Date
April 21 2023
Last Update
May 6 2023
Active Locations (121)
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1
Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan, 493-0004
2
Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan, 494-0001
3
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 460-0004
4
Novartis Investigative Site
Nishio, Aichi-ken, Japan, 444-0403