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NCT03814187 · ClinicalTrials.gov registry record · Phase 3
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,275
- Enrollment target
NCT03814187: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03814187 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 3,275 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (324% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03814187, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,275 participants
- Enrollment target
Study Summary
The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
Primary Outcome
The primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study (EOS). Target is \<70 mg/dL for atherosclerotic cardiovascular disease (ASCVD) subjects and \<100 mg/dL for ASCVD risk equivalent subjects. Risk equivalent subjects are defined as either type 2 diabetes, familial hypercholesterolemia or a 10-year risk of a cardiovascular event ≥20% as assessed by the Framingham Risk Score or equ
Interventions
- DRUG Inclisiran Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,275 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2023-02-13 |
| Phase | Phase 3 |
What the finished NCT03814187 record still lists
NCT03814187 is an interventional study that assigns participants to a tested intervention. Its 3,275 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 (324% higher).
The record links to 0 conditions, and to 1 intervention - of which Inclisiran Sodium is the first listed.
NCT03814187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03814187 about?
NCT03814187 is a clinical study titled "Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C". The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
What is the current status of trial NCT03814187?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,275 participants. The study started on 2019-04-16. Estimated completion is 2023-02-13.
What interventions are being tested in trial NCT03814187?
The interventions under investigation include: Inclisiran Sodium (DRUG).
Who is sponsoring clinical trial NCT03814187?
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 NCT03814187's enrollment target sits among peer trials
3,275 73rd of 2000 higher than 1,928 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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