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Trial record 1 of 1 for:    NCT03785405
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03785405
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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 : April 21, 2022
Estimated Study Completion Date : May 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Loma Linda, California, United States, 92354
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90095
Novartis Investigative Site Recruiting
Palo Alto, California, United States, 94304
United States, Florida
Novartis Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Indiana
Novartis Investigative Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48109-5238
United States, Minnesota
Novartis Investigative Site Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Novartis Investigative Site Recruiting
New York, New York, United States, 10032
United States, North Carolina
Novartis Investigative Site Recruiting
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Novartis Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Bulgaria
Novartis Investigative Site Recruiting
Sofia, Bulgaria, 1309
Canada, Alberta
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Croatia
Novartis Investigative Site Recruiting
Zagreb, Croatia, 10000
Czechia
Novartis Investigative Site Recruiting
Praha 5, Czechia, 150 06
Israel
Novartis Investigative Site Recruiting
Be'er-Sheva, Israel, 84101
Italy
Novartis Investigative Site Recruiting
Bergamo, BG, Italy, 24127
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50132
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00165
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Recruiting
Obu, Aichi, Japan, 474 8710
Novartis Investigative Site Recruiting
Sapporo city, Hokkaido, Japan, 060 8648
Novartis Investigative Site Recruiting
Omura, Nagasaki, Japan, 856-8562
Novartis Investigative Site Recruiting
Bunkyo ku, Tokyo, Japan, 113 8655
Novartis Investigative Site Recruiting
Shinjuku ku, Tokyo, Japan, 162 8666
Korea, Republic of
Novartis Investigative Site Recruiting
Yangsan Si, Gyeongsangnam Do, Korea, Republic of, 50612
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03722
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 06351
Lebanon
Novartis Investigative Site Recruiting
Ashrafieh, Lebanon, 166830
Poland
Novartis Investigative Site Recruiting
Warszawa, Poland, 04 730
Novartis Investigative Site Recruiting
Wroclaw, Poland, 51-124
Portugal
Novartis Investigative Site Recruiting
Carnaxide, Lisboa, Portugal, 2799 523
Novartis Investigative Site Recruiting
Coimbra, Portugal, 3000 075
Novartis Investigative Site Recruiting
Lisboa, Portugal, 1169 024
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 119260
South Africa
Novartis Investigative Site Recruiting
Soweto, Gauteng, South Africa, 2013
Switzerland
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Taiwan
Novartis Investigative Site Recruiting
Tainan, Taiwan, 70403
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10041
Thailand
Novartis Investigative Site Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10400
Turkey
Novartis Investigative Site Recruiting
Ankara, Turkey, 06490
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Konak/Izmir, Turkey, 35210
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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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: May 15, 2020
Last Verified: May 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: 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
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action