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NCT02678312 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 393
- Enrollment target
NCT02678312: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02678312 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 393 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (195% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02678312, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 393 participants
- Enrollment target
Study 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.
Primary Outcome
The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).
Interventions
- DRUG LCZ696
- DRUG Enalapril
- DRUG Placebo of LCZ696
- DRUG Placebo of Enalapril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2022-01-03 |
| Phase | Phase 2 |
What the finished NCT02678312 record still lists
NCT02678312 is an interventional study that assigns participants to a tested intervention. The registered 393 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (195% higher).
The record links to 0 conditions, and to 4 interventions - of which LCZ696 is the first listed.
NCT02678312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02678312 about?
NCT02678312 is a clinical study titled "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". 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 effectivene...
What is the current status of trial NCT02678312?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 393 participants. The study started on 2016-11-03. Estimated completion is 2022-01-03.
What interventions are being tested in trial NCT02678312?
The interventions under investigation include: LCZ696 (DRUG), Enalapril (DRUG), Placebo of LCZ696 (DRUG), Placebo of Enalapril (DRUG).
Who is sponsoring clinical trial NCT02678312?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02678312's enrollment target sits among peer trials
393 104th of 2000 higher than 1,896 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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