Heart Failure Clinical Trial

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

Summary

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes 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 a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

View Full Description

Full Description

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes 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 a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Chronic heart failure (CHF) resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
New York Heart Association (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 ≤ 45% or fractional shortening ≤22.5%
For Part 1 study: Patients must be treated with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (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 is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

393

Study ID:

NCT02678312

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 97 Locations for this study

See Locations Near You

Novartis Investigative Site
Loma Linda California, 92354, United States
Novartis Investigative Site
Los Angeles California, 90027, United States
Novartis Investigative Site
Los Angeles California, 90095, United States
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Palo Alto California, 94304, United States
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San Diego California, 92123, United States
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Aurora Colorado, 80045, United States
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Gainesville Florida, 32610, United States
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Miami Florida, 33136, United States
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Saint Petersburg Florida, 33701, United States
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Atlanta Georgia, 30322, United States
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Indianapolis Indiana, 46202, United States
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Boston Massachusetts, 02115, United States
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Ann Arbor Michigan, 48109, United States
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Minneapolis Minnesota, 55455, United States
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Rochester Minnesota, 55905, United States
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Saint Louis Missouri, 63110, United States
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New York New York, 10029, United States
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New York New York, 10032, United States
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Charlotte North Carolina, 28203, United States
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Cleveland Ohio, 44195, United States
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Philadelphia Pennsylvania, 19104, United States
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Pittsburgh Pennsylvania, 15224, United States
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Dallas Texas, 75235, United States
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Salt Lake City Utah, 84113, United States
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Seattle Washington, 98105, United States
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Ramos Mejia Buenos Aires, B1704, Argentina
Novartis Investigative Site
Ciudad de Salta Provincia De Salta, A4406, Argentina
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Innsbruck , 6020, Austria
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Sofia , 1309, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Toronto Ontario, M5G 1, Canada
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Guangzhou Guangdong, 51062, China
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Beijing , 10003, China
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Shanghai , 20006, China
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Shanghai , 20012, China
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Zagreb , 10000, Croatia
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Praha 5 , 150 0, Czechia
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Helsinki , 00290, Finland
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Montpellier , 34295, France
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Paris , 75015, France
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Pessac , 33600, France
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Berlin , 13353, Germany
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Erlangen , 91054, Germany
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Freiburg , 79106, Germany
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Heidelberg , 69120, Germany
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Leipzig , 04289, Germany
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Stuttgart , 70174, Germany
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Budapest , H 109, Hungary
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New Delhi Delhi, 110 0, India
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New Delhi Delhi, 11007, India
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Ahmedabad Gujarat, 380 0, India
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Kochi Kerala, 68204, India
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Be'er-Sheva , 84101, Israel
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Bergamo BG, 24127, Italy
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Bologna BO, 40138, Italy
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Firenze FI, 50132, Italy
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Milano MI, 20162, Italy
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Padova PD, 35128, Italy
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Roma RM, 00165, Italy
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Torino TO, 10126, Italy
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Napoli , 80131, Italy
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Obu Aichi, 474 8, Japan
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Sapporo city Hokkaido, 060 8, Japan
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Omura Nagasaki, 856-8, Japan
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Bunkyo ku Tokyo, 113 8, Japan
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Setagaya-ku Tokyo, 157-8, Japan
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Shinjuku ku Tokyo, 162 8, Japan
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Toyama-city Toyama, 930-0, Japan
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Saitama , 330 8, Japan
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Amman JOR, 11183, Jordan
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Yangsan Gyeongsangnam Do, 50612, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Beirut , , Lebanon
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El Achrafîyé , 16683, Lebanon
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Gdansk , 80-95, Poland
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Warszawa , 04 73, Poland
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Carnaxide Lisboa, 2799 , Portugal
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Coimbra , 3000 , Portugal
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Lisboa , 1169 , Portugal
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Moscow , 12541, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Riyadh , 11211, Saudi Arabia
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Singapore , 22989, Singapore
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Cordoba Andalucia, 14004, Spain
Novartis Investigative Site
Barcelona Cataluna, 08950, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
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Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28046, Spain
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Lausanne , 1011, Switzerland
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Kaohsiung City , 83301, Taiwan
Novartis Investigative Site
Taipei , 10041, Taiwan
Novartis Investigative Site
Bangkoknoi Bangkok, 10700, Thailand
Novartis Investigative Site
Bangkok , 10400, Thailand
Novartis Investigative Site
Ankara , 06490, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
Novartis Investigative Site
Konak , 35210, Turkey

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

393

Study ID:

NCT02678312

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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