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CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

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: NCT03785405
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: sacubitril/valsartan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: N/A
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: sacubitril/valsartan
single arm, open label sacubitril/valsartan
 Drug: sacubitril/valsartan

Target dose 3.1 mg/kg bid

Formulations:

Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)

Other Name: LCZ696


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [ Time Frame: to end of study, up to 3 years ]
    Safety. Assessments include: Adverse Events (AEs)

  2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability [ Time Frame: to end of study, up to 3 years ]
    Safety. Assessments include: Serious Adverse Events (SAEs)


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue

Exclusion Criteria:

  • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2
  • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires >/=36-hour washout before baseline visit)
  • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan
  • Renal vascular hypertension (including renal artery stenosis)
  • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula <30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder
  • History of angioedema
  • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures
  • Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study
  • Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
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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): NCT03785405


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03785405    
Other Study ID Numbers: CLCZ696B2319E1
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
heart failure
pediatric
LCZ696
 sacubitril/valsartan
open-label study
angiotensin receptor neprilysin inhibitor
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
Sacubitril and valsartan sodium hydrate drug combination
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action