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NCT02226120 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,980
- Enrollment target
NCT02226120: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02226120 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,980 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02226120, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,980 participants
- Enrollment target
Study Summary
The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.
Primary Outcome
The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
Interventions
- DRUG LCZ696
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,980 participants |
| Start Date | 2014-10-16 |
| Est. Completion | 2017-12-28 |
| Phase | Phase 3 |
What the finished NCT02226120 record still lists
NCT02226120 is an interventional study that assigns participants to a tested intervention. Its 1,980 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher).
The record links to 0 conditions, and to 1 intervention - of which LCZ696 is the first listed.
NCT02226120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02226120 about?
NCT02226120 is a clinical study titled "Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction". The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with redu...
What is the current status of trial NCT02226120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,980 participants. The study started on 2014-10-16. Estimated completion is 2017-12-28.
What interventions are being tested in trial NCT02226120?
The interventions under investigation include: LCZ696 (DRUG).
Who is sponsoring clinical trial NCT02226120?
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 NCT02226120's enrollment target sits among peer trials
1,980 106th of 2000 higher than 1,894 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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