An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.

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)

ClinicalTrials.gov Identifier: NCT03909295

Novartis Reference Number: CLCZ696D1301E1

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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. 

Study Description

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.

Condition 
Heart Failure With Preserved Ejection Fraction (HFpEF)
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
63 participants
Start date 
May 07, 2019
Completion date 
Apr 15, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LCZ696
LCZ696 50 mg,100 mg,200 mg film coated tablets

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 Eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of LCZ696 per the investigator's assessment.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

Study Locations

Japan
Novartis Investigative Site
Recruiting
Seto-city, 489-8642
Aichi
Japan
Novartis Investigative Site
Recruiting
Chikushino-city, 818-8516
Fukuka
Japan
Novartis Investigative Site
Recruiting
Ogaki-city, 503-8502
Gifu
Japan
Novartis Investigative Site
Active, not recruiting
Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
Recruiting
Kanazawa, 920 8650
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Morioka, 020 0066
Iwate
Japan
Novartis Investigative Site
Recruiting
Kanonji-city, 769-1695
Kagawa
Japan
Novartis Investigative Site
Recruiting
Takamatsu city, 760 8557
Kagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 227-8501
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama-city, 236 0051
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
Recruiting
Kashihara city, 634 8522
Nara
Japan
Novartis Investigative Site
Recruiting
Sayama-city, 350-1305
Saitama
Japan
Novartis Investigative Site
Active, not recruiting
Kusatsu city, 525 8585
Shiga
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0918
Tokyo
Japan
Novartis Investigative Site
Recruiting
Itabashi-ku, 173-8610
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinagawa-ku, 142-8666
Tokyo
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+81337978748
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]