NCT02678312

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pediatric Heart Failure

Interventions

Type	Name	Description
DRUG	LCZ696	LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules)
DRUG	Enalapril	Enalapril tablets: 2.5 mg, 5 mg, 10 mg dosage strengths
DRUG	Placebo of LCZ696
DRUG	Placebo of Enalapril
DRUG	LCZ696	LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), tablets: 50 mg, 100 mg, 200 mg dosage strengths

Timeline

• Start date: 2016-11-03
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2016-02-09
• Last updated: 2023-02-10
• Results posted: 2023-02-10

Locations

98 sites across 29 countries: United States, Argentina, Austria, Bulgaria, Canada, China, Croatia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study