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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909295
Recruitment Status : Terminated (This study was terminated early because the primary endpoint of PARAGON-HF was not met.)
First Posted : April 10, 2019
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction (HFpEF) Drug: LCZ696 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 7, 2019
Actual Primary Completion Date : November 19, 2019
Actual Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: LCZ696
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
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
Other Name: Sacubitril/valsartan




Primary Outcome Measures :
  1. Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to 27 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909295


Locations
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Japan
Novartis Investigative Site
Seto-city, Aichi, Japan, 489-8642
Novartis Investigative Site
Chikushino-city, Fukuoka, Japan, 818-8516
Novartis Investigative Site
Ogaki-city, Gifu, Japan, 503-8502
Novartis Investigative Site
Maebashi city, Gunma, Japan, 371 8511
Novartis Investigative Site
Kanazawa, Ishikawa, Japan, 920 8650
Novartis Investigative Site
Morioka, Iwate, Japan, 020 0066
Novartis Investigative Site
Kanonji-city, Kagawa, Japan, 769-1695
Novartis Investigative Site
Takamatsu city, Kagawa, Japan, 760 8557
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 227-8501
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 236 0051
Novartis Investigative Site
Sendai city, Miyagi, Japan, 980 8574
Novartis Investigative Site
Kashihara city, Nara, Japan, 634 8522
Novartis Investigative Site
Sayama-city, Saitama, Japan, 350-1305
Novartis Investigative Site
Kusatsu city, Shiga, Japan, 525 8585
Novartis Investigative Site
Hachioji-city, Tokyo, Japan, 192-0918
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 142-8666
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] December 17, 2019
Study Protocol  [PDF] December 17, 2018

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03909295    
Other Study ID Numbers: CLCZ696D1301E1
First Posted: April 10, 2019    Key Record Dates
Results First Posted: December 4, 2020
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
heart failure with preserved ejection fraction, Japanese patients, extension study, long-term safety and tolerability, open-label
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action