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

NCT03909295 | Terminated Phase 3 Results

• 1 other identifier: CLCZ696D1301E1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 17

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).

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events and Serious Adverse Events

  An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.

  Up to 27 weeks

Study Arms (1)

LCZ696

EXPERIMENTAL

Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient

Drug: LCZ696

Interventions

LCZ696 DRUG

Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient

Also known as: Sacubitril/valsartan

LCZ696

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Seto, Aichi-ken, 489-8642, Japan

Location

Novartis Investigative Site

Chikushino-shi, Fukuoka, 818-8516, Japan

Location

Novartis Investigative Site

Ōgaki, Gifu, 503-8502, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Kanazawa, Ishikawa-ken, 920 8650, Japan

Location

Novartis Investigative Site

Morioka, Iwate, 020 0066, Japan

Location

Novartis Investigative Site

Kan’onjichō, Kagawa-ken, 769-1695, Japan

Location

Novartis Investigative Site

Takamatsu, Kagawa-ken, 760 8557, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 227-8501, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236 0051, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Kashihara, Nara, 634 8522, Japan

Location

Novartis Investigative Site

Sayama, Saitama, 350-1305, Japan

Location

Novartis Investigative Site

Kusatsu, Shiga, 525 8585, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0918, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: May 7, 2019
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: October 8, 2021
• Results First Posted: December 4, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (17)