- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785405
CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Provincia De Salta
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Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
- Novartis Investigative Site
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Innsbruck, Austria, 6020
- Novartis Investigative Site
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Sofia, Bulgaria, 1309
- Novartis Investigative Site
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Alberta
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Edmonton, Alberta, Canada, T6G 1C9
- Novartis Investigative Site
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Novartis Investigative Site
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Zagreb, Croatia, 10000
- Novartis Investigative Site
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Praha 5, Czechia, 150 06
- Novartis Investigative Site
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Helsinki, Finland, 00290
- Novartis Investigative Site
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Paris 15, France, 75015
- Novartis Investigative Site
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Berlin, Germany, 13353
- Novartis Investigative Site
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Erlangen, Germany, 91054
- Novartis Investigative Site
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Freiburg, Germany, 79106
- Novartis Investigative Site
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Heidelberg, Germany, 69120
- Novartis Investigative Site
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Stuttgart, Germany, 70174
- Novartis Investigative Site
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Budapest, Hungary, H 1096
- Novartis Investigative Site
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New Delhi, India, 110029
- Novartis Investigative Site
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Delhi
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New Delhi, Delhi, India, 110076
- Novartis Investigative Site
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Gujarat
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Ahmedabad, Gujarat, India, 380 060
- Novartis Investigative Site
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Kerala
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Kochi, Kerala, India, 682041
- Novartis Investigative Site
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Be'er-Sheva, Israel, 84101
- Novartis Investigative Site
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Napoli, Italy, 80131
- Novartis Investigative Site
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BG
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Bergamo, BG, Italy, 24127
- Novartis Investigative Site
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BO
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Bologna, BO, Italy, 40138
- Novartis Investigative Site
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FI
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Firenze, FI, Italy, 50132
- Novartis Investigative Site
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MI
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Milano, MI, Italy, 20162
- Novartis Investigative Site
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RM
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Roma, RM, Italy, 00165
- Novartis Investigative Site
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TO
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Torino, TO, Italy, 10126
- Novartis Investigative Site
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Saitama, Japan, 330 8777
- Novartis Investigative Site
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Aichi
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Obu, Aichi, Japan, 474 8710
- Novartis Investigative Site
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Hokkaido
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Sapporo city, Hokkaido, Japan, 060 8648
- Novartis Investigative Site
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Nagasaki
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Omura, Nagasaki, Japan, 856-8562
- Novartis Investigative Site
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Tokyo
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Bunkyo ku, Tokyo, Japan, 113 8655
- Novartis Investigative Site
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Setagaya-ku, Tokyo, Japan, 157-8535
- Novartis Investigative Site
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Shinjuku ku, Tokyo, Japan, 162 8666
- Novartis Investigative Site
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Toyama
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Toyama-city, Toyama, Japan, 930-0194
- Novartis Investigative Site
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Seoul, Korea, Republic of, 03080
- Novartis Investigative Site
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Seoul, Korea, Republic of, 06351
- Novartis Investigative Site
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Seoul, Korea, Republic of, 03722
- Novartis Investigative Site
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Gyeongsangnam Do
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Yangsan Si, Gyeongsangnam Do, Korea, Republic of, 50612
- Novartis Investigative Site
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Ashrafieh, Lebanon, 166830
- Novartis Investigative Site
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Beirut, Lebanon, 10999
- Novartis Investigative Site
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Warszawa, Poland, 04 730
- Novartis Investigative Site
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Wroclaw, Poland, 51-124
- Novartis Investigative Site
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Coimbra, Portugal, 3000 075
- Novartis Investigative Site
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Lisboa, Portugal, 1169 024
- Novartis Investigative Site
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Lisboa
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Carnaxide, Lisboa, Portugal, 2799 523
- Novartis Investigative Site
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Moscow, Russian Federation, 125412
- Novartis Investigative Site
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Saint Petersburg, Russian Federation, 197341
- Novartis Investigative Site
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Singapore, Singapore, 119260
- Novartis Investigative Site
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Singapore, Singapore, 229899
- Novartis Investigative Site
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Gauteng
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Soweto, Gauteng, South Africa, 2013
- Novartis Investigative Site
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Madrid, Spain, 28046
- Novartis Investigative Site
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Madrid, Spain, 28009
- Novartis Investigative Site
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Andalucia
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Cordoba, Andalucia, Spain, 14004
- Novartis Investigative Site
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Cataluna
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Barcelona, Cataluna, Spain, 08950
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spain, 08035
- Novartis Investigative Site
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Lausanne, Switzerland, 1011
- Novartis Investigative Site
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Tainan, Taiwan, 70403
- Novartis Investigative Site
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Taipei, Taiwan, 10041
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Novartis Investigative Site
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Ankara, Turkey, 06490
- Novartis Investigative Site
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Izmir, Turkey, 35040
- Novartis Investigative Site
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Konak-Izmir, Turkey, 35210
- Novartis Investigative Site
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California
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Loma Linda, California, United States, 92354
- Novartis Investigative Site
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Los Angeles, California, United States, 90095
- Novartis Investigative Site
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Palo Alto, California, United States, 94304
- Novartis Investigative Site
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Florida
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Saint Petersburg, Florida, United States, 33701
- Novartis Investigative Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Novartis Investigative Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Novartis Investigative Site
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Michigan
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Ann Arbor, Michigan, United States, 48109-5238
- Novartis Investigative Site
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Novartis Investigative Site
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Rochester, Minnesota, United States, 55905
- Novartis Investigative Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Novartis Investigative Site
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New York
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New York, New York, United States, 10032
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Novartis Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, United States, 15224
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: sacubitril/valsartan
single arm, open label sacubitril/valsartan
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Time Frame: to end of study, up to 3 years
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Safety.
Assessments include: Adverse Events (AEs)
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to end of study, up to 3 years
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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
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Safety.
Assessments include: Serious Adverse Events (SAEs)
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to end of study, up to 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLCZ696B2319E1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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