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NCT03399370 · ClinicalTrials.gov registry record · Phase 3
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
A Phase 3 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,561
- Enrollment target
NCT03399370: Completed Phase 3 study, sponsored by The Medicines Company.
NCT03399370 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 1,561 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03399370, a Phase 3 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,561 participants
- Enrollment target
Study Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
Interventions
- DRUG Placebo
- DRUG Inclisiran Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,561 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2019-09-17 |
| Phase | Phase 3 |
What the finished NCT03399370 record still lists
NCT03399370 is an interventional study that assigns participants to a tested intervention. Its 1,561 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 (102% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03399370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03399370 about?
NCT03399370 is a clinical study titled "Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol". This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multic...
What is the current status of trial NCT03399370?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,561 participants. The study started on 2017-12-21. Estimated completion is 2019-09-17.
What interventions are being tested in trial NCT03399370?
The interventions under investigation include: Placebo (DRUG), Inclisiran Sodium (DRUG).
Who is sponsoring clinical trial NCT03399370?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03399370's enrollment target sits among peer trials
1,561 150th of 2000 higher than 1,851 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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