Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03397121 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
A Phase 3 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
NCT03397121 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 482 participants.
The verdict
NCT03397121, a Phase 3 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
Study Summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
Interventions
- DRUG Placebo
- DRUG Inclisiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2019-09-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03397121
The ClinicalTrials.gov registry entry for NCT03397121 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Medicines Company, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03397121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03397121 about?
NCT03397121 is a clinical study titled "Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)". This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
What is the current status of trial NCT03397121?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2017-11-28. Estimated completion is 2019-09-17.
What interventions are being tested in trial NCT03397121?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT03397121?
This trial is sponsored by The Medicines Company, which has 35 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.