Clinical trial NCT03909295: An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords: heart failure with preserved ejection fraction, Japanese patients, extension study, long-term safety and tolerability, open-label
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).

Detailed description: This study was an open-label extension study following the PARAGON-HF. Patients who have completed the PARAGON-HF were eligible to participate. During the study, open-label LCZ696 was taken in addition to background treatments of comorbidities. All subjects were treated with LCZ696 (sacubitril/valsartan) at maximally tolerated dosed with a target dose of 200 mg b.i.d (twice a day).

The subject were to continue to receive LCZ696 until it became commercially available, or for a period up to 24 months from the first patient enrolled in this study whichever came first. However, this study was terminated early based on the pre-defined early termination criteria of "the primary endpoint of PARAGONHF was not met" in the protocol.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 Eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of LCZ696 per the investigator's assessment.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.

Primary outcomes:
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to 27 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seto-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Chikushino-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Ogaki-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kanonji-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Takamatsu city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Sayama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kusatsu city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
References: