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
Public ClinicalTrials.gov record NCT02678312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02678312
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 393 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 3, 2016 (Actual)
- Primary completion
- Jan 3, 2022 (Actual)
- Completion
- Jan 3, 2022 (Actual)
- Last update posted
- Feb 10, 2023
2016 – 2022
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Loma Linda | California | 92354 | — |
| Novartis Investigative Site | Los Angeles | California | 90027 | — |
| Novartis Investigative Site | Los Angeles | California | 90095 | — |
| Novartis Investigative Site | Palo Alto | California | 94304 | — |
| Novartis Investigative Site | San Diego | California | 92123 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Gainesville | Florida | 32610 | — |
| Novartis Investigative Site | Miami | Florida | 33136 | — |
| Novartis Investigative Site | St. Petersburg | Florida | 33701 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30322 | — |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | — |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109-5238 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | — |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | — |
| Novartis Investigative Site | St Louis | Missouri | 63110 | — |
| Novartis Investigative Site | New York | New York | 10029 | — |
| Novartis Investigative Site | New York | New York | 10032 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28203 | — |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 4399 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15224 | — |
| Novartis Investigative Site | Dallas | Texas | 75235 | — |
| Novartis Investigative Site | Salt Lake City | Utah | 84113 | — |
| Novartis Investigative Site | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02678312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2023 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02678312 live on ClinicalTrials.gov.