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

ClinicalTrials.gov Identifier: NCT03785405

Novartis Reference Number: CLCZ696B2319E1

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Heart Failure
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
240 participants
Start date 
May 02, 2019
Completion date 
Dec 31, 2022
Gender 
All
Age(s)
1 Years - 18 Years (Child, Adult)

Interventions

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)

Eligibility 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

Study Locations

United States
Novartis Investigative Site
Recruiting
Loma Linda, 92354
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90095
California
United States
Novartis Investigative Site
Recruiting
Palo Alto, 94304
California
United States
Novartis Investigative Site
Recruiting
Saint Petersburg, 33701
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30322
Georgia
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46202
Indiana
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48109-5238
Michigan
United States
Novartis Investigative Site
Recruiting
Minneapolis, 55455
Minnesota
United States
Novartis Investigative Site
Recruiting
Rochester, 55905
Minnesota
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63110
Missouri
United States
Novartis Investigative Site
Recruiting
New York, 10032
New York
United States
Novartis Investigative Site
Recruiting
Charlotte, 28203
North Carolina
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19104
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15224
Pennsylvania
United States
Argentina
Novartis Investigative Site
Recruiting
Ciudad de Salta, A4406BPF
Provincia De Salta
Argentina
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1309
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Edmonton, T6G 1C9
Alberta
Canada
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
Czechia
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czechia
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, H 1096
-
Hungary
India
Novartis Investigative Site
Recruiting
New Delhi, 110076
Delhi
India
Novartis Investigative Site
Recruiting
Ahmedabad, 380 060
Gujarat
India
Israel
Novartis Investigative Site
Recruiting
Be'er-Sheva, 84101
-
Israel
Italy
Novartis Investigative Site
Recruiting
Bergamo, 24127
BG
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
BO
Italy
Novartis Investigative Site
Recruiting
Firenze, 50132
FI
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Novartis Investigative Site
Recruiting
Torino, 10126
TO
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
Recruiting
Obu, 474 8710
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Omura, 856-8562
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 162 8666
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Yangsan Si, 50612
Gyeongsangnam Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06351
-
Korea, Republic of
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Recruiting
Beirut,
-
Lebanon
Poland
Novartis Investigative Site
Recruiting
Warszawa, 04 730
-
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 51-124
-
Poland
Portugal
Novartis Investigative Site
Recruiting
Carnaxide, 2799 523
Lisboa
Portugal
Novartis Investigative Site
Recruiting
Coimbra, 3000 075
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1169 024
-
Portugal
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119260
-
Singapore
South Africa
Novartis Investigative Site
Recruiting
Soweto, 2013
Gauteng
South Africa
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1011
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10041
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Bangkoknoi, 10700
Bangkok
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06490
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Konak/Izmir, 35210
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]