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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:3/7/2019
Start Date:November 3, 2016
End Date:April 21, 2021
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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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

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.


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
We found this trial at
36
sites
Miami, Florida 33136
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30322
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Aurora, Colorado 80010
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Boston, Massachusetts 02118
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Bronx, New York 10461
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Dallas, Texas 75216
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Durham, North Carolina 27710
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Gainesville, Florida 32608
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Hollywood, Florida 33021
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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Kansas City, Missouri 64111
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Loma Linda, California 92354
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Memphis, Tennessee 38120
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Milwaukee, Wisconsin 53209
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Minneapolis, Minnesota 55402
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New Haven, Connecticut
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Omaha, Nebraska 68144
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15224
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Ramos Mejia, Buenos Aires
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63128
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84103
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San Diego, California 92123
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Seattle, Washington 98103
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