Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 393 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02678312
The ClinicalTrials.gov registry entry for NCT02678312 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 393 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which LCZ696 is the first listed.
NCT02678312 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.