A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of LCZ696 Treatment in Japanese Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction After CLCZ696D2301 (PARAGON-HF)
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of this open-label study is to evaluate long-term safety and tolerability of LCZ696 in eligible heart failure with preserved ejection fraction (HFpEF) patients who completed PARAGON-HF in Japan.
Heart Failure With Preserved Ejection Fraction (HFpEF)
Sep 26, 2019
May 07, 2019
Apr 15, 2021
18 Years and older (Adult, Older Adult)
LCZ696 50 mg,100 mg,200 mg film coated tablets
Signed informed consent must be obtained before any assessment is performed.
Patients who have completed LCZ696D2301 and are able to be safely enrolled into this study as judged by the investigator.
Patients who discontinued study drug treatment during LCZ696D2301 due to an event or intercurrent illness. Eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of LCZ696 per the investigator's assessment.
Any medical condition that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Patients who have experience of angioedema event(s) which occurred and reported by the investigator during LCZ696D2301.
Pregnant or nursing (lactating) women.
Women of childbearing potential unless they are using highly effective methods of contraception.
Other protocol-defined inclusion/exclusion may apply.