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NCT05682378 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
A Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 20
- Study locations
NCT05682378 is a Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 131 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT05682378, a Phase 3 study of Heterozygous or Homozygous Familial Hypercholesterolemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
Conditions Studied
Interventions
- DRUG Inclisiran
Study Locations (20)
Other
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Besançon
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Freiburg im Breisgau
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Jerusalem
São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
New York
- Icahn School of Med at Mt Sinai - New York
Ohio
- Cincinnati Childrens Hospital MC - Cincinnati
Pennsylvania
- Childrens Hosp Pittsburgh UPMC - Pittsburgh
Utah
- Primary Childrens Medical Center - Salt Lake City
Formosa Province
- Novartis Investigative Site - Formosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2028-03-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05682378
The ClinicalTrials.gov registry entry for NCT05682378 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 131 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 1 condition, with Heterozygous or Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which Inclisiran is the first listed.
NCT05682378 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, São Paulo, Florida.
Frequently Asked Questions
What is clinical trial NCT05682378 about?
NCT05682378 is a clinical study titled "Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies". The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
What is the current status of trial NCT05682378?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2023-02-10. Estimated completion is 2028-03-02.
What conditions does trial NCT05682378 study?
This clinical trial studies the following conditions: Heterozygous or Homozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT05682378?
The interventions under investigation include: Inclisiran (DRUG).
Who is sponsoring clinical trial NCT05682378?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05682378 being conducted?
This trial has 20 study locations across Florida, New York, Ohio, Pennsylvania, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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