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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

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ClinicalTrials.gov Identifier: NCT02678312
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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 or disease Intervention/treatment Phase
Pediatric Heart Failure Drug: LCZ696 Drug: Enalapril Drug: Placebo of LCZ696 Drug: Placebo of Enalapril Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Part 1: LCZ696 open label
LCZ696 open label either 1) 0.8 mg/kg or 2) 3.1 mg/kg or both. After LCZ696 PK assessment, patients will be maintained on open-label Enalapril or standard of care for heart failure treatment, if patient consents to participate in Part 2.
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

Active Comparator: Part 2: Enalapril
The target dose for enalapril is 0.2 mg/kg bid (0.4 mg/kg total daily dose) with a maximum dose of 10 mg bid (20 mg total daily dose).
Drug: Enalapril
Enalapril will be open label in Part 1 and double blind in Part 2

Drug: Placebo of LCZ696
Experimental: Part 2:LCZ696
LCZ696 3.125 mg granules and adult formulation (50, 100, 200 mg) can be given based on patient weight.
Drug: LCZ696
LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), 50 mg, 100 mg, 200 mg dosage strengths

Drug: Placebo of Enalapril



Primary Outcome Measures :
  1. Part 1: Pharmacokinetics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Maximum drug concentration in plasma (Cmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, and optional 24 hours post dosing ]
    Cmax will be determined for LCZ696 analytes (sacubitril, LBQ657, and valsartan) by using non-compartmental methods.

  2. Part 1: Pharmacokinetics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Time to maximum plasma concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, and optional 24 hours post dosing ]
    Tmax will be determined for LCZ696 analytes (sacubitril, LBQ657, and valsartan) by using non-compartmental methods.

  3. Part 1: Pharmacokinetics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): area under the plasma concentration-time curve from time zero to infinity (AUCinf) and area under the plasma concentration-time curve from time zero to last (AUClast) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, and optional 24 hours post dosing ]
    AUCinf and AUClast will be determined for LCZ696 analytes (sacubitril, LBQ657, and valsartan) by using non-compartmental methods.

  4. Part 1: Pharmacokinetics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Clearance from plasma (CL/F) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, and optional 24 hours post dosing ]
    CL/F will be determined for LCZ696 analytes (sacubitril, LBQ657, and valsartan) by using non-compartmental methods.

  5. Part 1: Pharmacokinetics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Time required to drug concentration to decrease by half (T 1/2) [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, and optional 24 hours post dosing ]
    T 1/2 will be determined for LCZ696 analytes (sacubitril, LBQ657, and valsartan) by using non-compartmental methods

  6. Part 1: Pharmacodynamics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Plasma N-terminal pro-brain natriuretic peptide (NTproBNP) [ Time Frame: 0 (pre-dose) and optional 24 hours post dosing ]
    The 24 hour post dose is optional depending on blood volume restrictions.

  7. Part 1: Pharmacodynamics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Plasma cyclic guanosine monophosphate (cGMP) [ Time Frame: 0 (pre-dose), 4 and, 8 hours post dosing ]
  8. Part 1: Pharmacodynamics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Urine cGMP [ Time Frame: 0 (pre-dose) hour and between 4 and 8 hours post dose ]
    One urine sample at 0 hr (predose) and another urine sample between 4 to 8 hours post-dose will be collected.

  9. Part 1: Pharmacodynamics of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Plasma B-type natriuretic peptide (BNP) [ Time Frame: 0 (pre-dose), 4 and 8 hour post dose ]
  10. Part 2: Percentage of patients falling into each category based on global ranking [ Time Frame: Up to 52 weeks ]
    The global ranking is based on clinical events such as death, listing for urgent heart transplant, mechanical life support requirement at end of study, worsening heart failure (HF), New York Heart Association (NYHA)/Ross, Patient Global Impression of Severity (PGIS), Pediatric Quality of Life Inventory (PedsQL) physical functioning domain. The primary endpoint will be derived based on 5 categories ranking worst to best outcome


Secondary Outcome Measures :
  1. Part 2: Time to first occurrence of Category 1 or Category 2 event [ Time Frame: 52 weeks ]
    Category 1: Death; United Network for Organ Sharing (UNOS) status 1A listing for heart transplant or equivalent; Ventricular assist device (VAD)/Extracorporeal membrane oxygenation (ECMO)/mechanical ventilation requirement for life support at end of study. Category 2: Worsening HF (WHF); defined by signs and symptoms of WHF that requires an intensification of HF therapy

  2. Part 2: Change from baseline in NYHA/Ross functional class [ Time Frame: Baseline to 52 weeks ]
    NYHA/Ross functional class will be compared through 52 weeks of double-blind treatment

  3. Part 2: Change from baseline in Patient Global impression of severity score (PGIS) scale [ Time Frame: Baseline to 52 weeks ]
    PGIS scale will be compared for LCZ696 and enalapril through 52 weeks of double-blind treatment

  4. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Clearance from plasma in steady state (CL,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter clearance will be estimated to be used in model.

  5. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Volume of distribution in steady state [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter volume of distribution will be estimated to be used in model.

  6. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Absorption rate constant in steady state (Ka,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter Ka will be estimated to be used in model.

  7. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Time required to drug concentration to decrease by half in steady state (T 1/2,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter T 1/2 will be estimated to be used in model.

  8. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Maximum drug concentration in plasma at steady state (Cmax,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter Cmax will be estimated to be used in model.

  9. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): Lowest plasma concentration observed during a dosing interval at steady state (Cmin,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter Cmin will be estimated to be used in model.

  10. Part 2: Population PK of LCZ696 analytes (sacubitril, LBQ657, and valsartan): area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [ Time Frame: Week 2, 12, 52 ]
    The steady state population PK parameter AUC will be estimated to be used in model.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02678312


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Novartis Investigative Site Recruiting
Loma Linda, California, United States, 92354
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90027
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90095
Novartis Investigative Site Recruiting
Palo Alto, California, United States, 94304
Novartis Investigative Site Recruiting
San Diego, California, United States, 92123
United States, Colorado
Novartis Investigative Site Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Novartis Investigative Site Completed
New Haven, Connecticut, United States, 06519
United States, Florida
Novartis Investigative Site Recruiting
Gainesville, Florida, United States, 32610
Novartis Investigative Site Recruiting
Hollywood, Florida, United States, 33021
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33136
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, Kentucky
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40202-3830
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
Minneapolis, Minnesota, United States, 55455
Novartis Investigative Site Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Novartis Investigative Site Recruiting
Kansas City, Missouri, United States, 64108
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Novartis Investigative Site Recruiting
Omaha, Nebraska, United States, 68198
United States, New York
Novartis Investigative Site Recruiting
Bronx, New York, United States, 10467
Novartis Investigative Site Completed
New York, New York, United States, 10029
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
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cincinnati, Ohio, United States, 45229-3039
Novartis Investigative Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104 4399
Novartis Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Novartis Investigative Site Recruiting
Memphis, Tennessee, United States, 38105
United States, Texas
Novartis Investigative Site Recruiting
Dallas, Texas, United States, 75235
Novartis Investigative Site Completed
Houston, Texas, United States, 77030
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Novartis Investigative Site Recruiting
Salt Lake City, Utah, United States, 84113
United States, Washington
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98105
United States, Wisconsin
Novartis Investigative Site Recruiting
Milwaukee, Wisconsin, United States, 53201-1997
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Novartis Investigative Site Recruiting
Ramos Mejia, Buenos Aires, Argentina, B1704ETD
Novartis Investigative Site Recruiting
Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
Austria
Novartis Investigative Site Recruiting
Graz, Austria, 8036
Novartis Investigative Site Recruiting
Innsbruck, Austria, 6020
Bulgaria
Novartis Investigative Site Recruiting
Sofia, Bulgaria, 1309
Canada, Alberta
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Canada, British Columbia
Novartis Investigative Site Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
China, Guangdong
Novartis Investigative Site Recruiting
Guangzhou, Guangdong, China, 510623
China
Novartis Investigative Site Recruiting
Beijing, China, 100037
Novartis Investigative Site Recruiting
Shanghai, China, 200062
Novartis Investigative Site Recruiting
Shanghai, China, 200127
Croatia
Novartis Investigative Site Recruiting
Zagreb, Croatia, 10000
Czechia
Novartis Investigative Site Recruiting
Ostrava Poruba, Czechia, 708 52
Novartis Investigative Site Recruiting
Praha 5, Czechia, 150 06
Finland
Novartis Investigative Site Recruiting
Helsinki, Finland, 00290
France
Novartis Investigative Site Recruiting
Montpellier, France, 34295 Cedex 5
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Paris, France, 75015
Novartis Investigative Site Recruiting
Pessac, France, 33600
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Bonn, Germany, 53105
Novartis Investigative Site Recruiting
Erlangen, Germany, 91054
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Leipzig, Germany, 04289
Novartis Investigative Site Completed
Saint Augustin, Germany, 53757
Novartis Investigative Site Recruiting
Stuttgart, Germany, 70174
Novartis Investigative Site Recruiting
Ulm, Germany, 89075
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, H 1096
India
Novartis Investigative Site Recruiting
New Delhi, Delhi, India, 110 060
Novartis Investigative Site Recruiting
New Delhi, Delhi, India, 110076
Novartis Investigative Site Recruiting
Ahmedabad, Gujarat, India, 380 060
Novartis Investigative Site Recruiting
Kochi, Kerala, India, 682041
Novartis Investigative Site Recruiting
Pune, Maharashtra, India, 411004
Novartis Investigative Site Recruiting
New Delhi, India, 110029
Israel
Novartis Investigative Site Recruiting
Be'er-Sheva, Israel, 84101
Italy
Novartis Investigative Site Recruiting
Bergamo, BG, Italy, 24127
Novartis Investigative Site Recruiting
Bologna, BO, Italy, 40138
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50132
Novartis Investigative Site Recruiting
Roma, ITA, Italy, 00165
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Recruiting
Torino, TO, Italy, 10126
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Japan
Novartis Investigative Site Terminated
Nagoya, Aichi, Japan, 453-8511
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
Fuchu-city, Tokyo, Japan, 183-8561
Novartis Investigative Site Recruiting
Setagaya-ku, Tokyo, Japan, 157-8535
Novartis Investigative Site Recruiting
Shinjuku ku, Tokyo, Japan, 162 8666
Novartis Investigative Site Recruiting
Toyama-city, Toyama, Japan, 930-0194
Novartis Investigative Site Recruiting
Saitama, Japan, 330 8777
Jordan
Novartis Investigative Site Recruiting
Amman, JOR, Jordan, 11183
Novartis Investigative Site Recruiting
Amman, Jordan, 11184
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
Novartis Investigative Site Recruiting
Beirut, Lebanon
Poland
Novartis Investigative Site Recruiting
Gdansk, Poland, 80-952
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 Active, not recruiting
Coimbra, Portugal, 3000 075
Novartis Investigative Site Recruiting
Lisboa, Portugal, 1169 024
Puerto Rico
Novartis Investigative Site Recruiting
Santurce, Puerto Rico, 00912
Romania
Novartis Investigative Site Recruiting
Targu Mures, Mures, Romania, 540136
Russian Federation
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 119991
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 125412
Novartis Investigative Site Recruiting
Saint Petersburg, Russian Federation, 197341
Saudi Arabia
Novartis Investigative Site Recruiting
Dammam, Saudi Arabia, 15215
Novartis Investigative Site Recruiting
Riyadh, Saudi Arabia, 11211
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 119260
Novartis Investigative Site Recruiting
Singapore, Singapore, 229899
South Africa
Novartis Investigative Site Recruiting
Soweto, Gauteng, South Africa, 2013
Spain
Novartis Investigative Site Recruiting
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Recruiting
Barcelona, Cataluna, Spain, 08035
Novartis Investigative Site Recruiting
Barcelona, Cataluna, Spain, 08950
Novartis Investigative Site Recruiting
Madrid, Spain, 28007
Novartis Investigative Site Recruiting
Madrid, Spain, 28046
Sweden
Novartis Investigative Site Recruiting
Goteborg, Sweden, SE 416 85
Novartis Investigative Site Recruiting
Lund, Sweden, 221 85
Switzerland
Novartis Investigative Site Recruiting
Geneve 14, Switzerland, 1211
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Taiwan
Novartis Investigative Site Recruiting
Kaohsiung City, Taiwan, 83301
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
Eskisehir, Turkey, 26040
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Konak/Izmir, Turkey, 35210
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02678312    
Other Study ID Numbers: CLCZ696B2319
2015-004207-22 ( EudraCT Number )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pediatric Heart failure,
systemic left ventricle,
reduced ejection fraction
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
LCZ 696
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin Receptor Antagonists