Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

ClinicalTrials.gov Identifier: NCT02678312

Novartis Reference Number: CLCZ696B2319

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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

This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.

The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.

Condition 
Pediatric Heart Failure
Phase 
Phase 2
Phase 3
Overall status 
Recruiting
Enrollment count 
360 participants
Start date 
Nov 03, 2016
Completion date 
Dec 31, 2021
Gender 
All
Age(s)
1 Years - 17 Years (Child)

Interventions

Drug
LCZ696
LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), 50 mg, 100 mg, 200 mg dosage strengths
Drug
Enalapril
Enalapril will be open label in Part 1 and double blind in Part 2
Drug
Placebo of LCZ696
Drug
Placebo of Enalapril

Eligibility Criteria

Key Inclusion Criteria:

Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
NYHA classification II-IV (older children: 6 to <18 years old) or Ross CHF classification II-IV (younger children: < 6 years old)
Systemic left ventricular ejection fraction ≤ 40% or fractional shortening ≤20%
For Part 1 study: Patients must be treated with an ACEI or ARB prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.
Biventricular physiology with systemic left ventricle

Key Exclusion Criteria:

Patient with single ventricle or systemic right ventricle
Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)
Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2
Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
Patients with restrictive or hypertrophic cardiomyopathy
Active myocarditis
Renal vascular hypertension (including renal artery stenosis)
Moderate-to severe obstructive pulmonary disease
Serum potassium > 5.3 mmol/L
History of angioedema
Allergy or hypersensitivity to ACEI / ARB

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85016
Arizona
United States
Novartis Investigative Site
Recruiting
Loma Linda, 92354
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90027
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
San Diego, 92123
California
United States
Novartis Investigative Site
Recruiting
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Withdrawn
New Haven, 06519
Connecticut
United States
Novartis Investigative Site
Recruiting
Gainesville, 32610
Florida
United States
Novartis Investigative Site
Recruiting
Hollywood, 33021
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
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
Louisville, 40202-3830
Kentucky
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
Kansas City, 64108
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63110
Missouri
United States
Novartis Investigative Site
Recruiting
Omaha, 68198
Nebraska
United States
Novartis Investigative Site
Withdrawn
Bronx, 10467
New York
United States
Novartis Investigative Site
Completed
New York, 10029
New York
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
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45229-3039
Ohio
United States
Novartis Investigative Site
Recruiting
Cleveland, 44195
Ohio
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19104 4399
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Pittsburgh, 15224
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Memphis, 38105
Tennessee
United States
Novartis Investigative Site
Recruiting
Dallas, 75235
Texas
United States
Novartis Investigative Site
Withdrawn
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84113
Utah
United States
Novartis Investigative Site
Recruiting
Seattle, 98105
Washington
United States
Novartis Investigative Site
Recruiting
Milwaukee, 53201-1997
Wisconsin
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ramos Mejia, B1704ETD
Buenos Aires
Argentina
Novartis Investigative Site
Active, not recruiting
Ciudad de Salta, A4406BPF
Provincia De Salta
Argentina
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
Novartis Investigative Site
Recruiting
Innsbruck, 6020
-
Austria
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1309
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Edmonton, T6G 1C9
Alberta
Canada
Novartis Investigative Site
Recruiting
Vancouver, V6H 3V4
British Columbia
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
China
Novartis Investigative Site
Recruiting
Guangzhou, 510623
Guangdong
China
Novartis Investigative Site
Recruiting
Beijing, 100037
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200062
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200127
-
China
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
Czechia
Novartis Investigative Site
Withdrawn
Ostrava Poruba, 708 52
-
Czechia
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czechia
Finland
Novartis Investigative Site
Recruiting
Helsinki, 00290
-
Finland
France
Novartis Investigative Site
Recruiting
Montpellier, 34295 Cedex 5
-
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Novartis Investigative Site
Recruiting
Pessac, 33600
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04289
-
Germany
Novartis Investigative Site
Withdrawn
Saint Augustin, 53757
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70174
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89075
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, H 1096
-
Hungary
India
Novartis Investigative Site
Recruiting
New Delhi, 110 060
Delhi
India
Novartis Investigative Site
Recruiting
New Delhi, 110076
Delhi
India
Novartis Investigative Site
Recruiting
Ahmedabad, 380 060
Gujarat
India
Novartis Investigative Site
Recruiting
Kochi, 682041
Kerala
India
Novartis Investigative Site
Withdrawn
Pune, 411004
Maharashtra
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India
Israel
Novartis Investigative Site
Recruiting
Be'er-Sheva, 84101
-
Israel
Novartis Investigative Site
Withdrawn
Petach-Tikva, 49202
-
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
Roma, 00165
ITA
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Padova, 35128
PD
Italy
Novartis Investigative Site
Recruiting
Torino, 10126
TO
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Japan
Novartis Investigative Site
Withdrawn
Nagoya, 453-8511
Aichi
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
Fuchu-city, 183-8561
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 162 8666
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toyama-city, 930-0194
Toyama
Japan
Novartis Investigative Site
Recruiting
Saitama, 330 8777
-
Japan
Jordan
Novartis Investigative Site
Recruiting
Amman, 11183
JOR
Jordan
Novartis Investigative Site
Recruiting
Amman, 11184
-
Jordan
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
Gdansk, 80-952
-
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
Active, not recruiting
Coimbra, 3000 075
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1169 024
-
Portugal
Puerto Rico
Novartis Investigative Site
Withdrawn
Santurce, 00912
-
Puerto Rico
Romania
Novartis Investigative Site
Recruiting
Targu Mures, 540136
Mures
Romania
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 119991
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 125412
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 197341
-
Russian Federation
Saudi Arabia
Novartis Investigative Site
Recruiting
Dammam, 15215
-
Saudi Arabia
Novartis Investigative Site
Recruiting
Riyadh, 11211
-
Saudi Arabia
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119260
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 229899
-
Singapore
South Africa
Novartis Investigative Site
Recruiting
Soweto, 2013
Gauteng
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7925
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Cataluna
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08950
Cataluna
Spain
Novartis Investigative Site
Recruiting
Madrid, 28007
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Goteborg, SE 416 85
-
Sweden
Novartis Investigative Site
Recruiting
Lund, 221 85
-
Sweden
Switzerland
Novartis Investigative Site
Recruiting
Geneve 14, 1211
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1011
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung City, 83301
-
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
Eskisehir, 26040
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Konak/Izmir, 35210
-
Turkey

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

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