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NCT04659863 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
A Phase 3 study of Familial Hypercholesterolemia - Homozygous, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
- 11
- Study locations
NCT04659863 is a Phase 3 study of Familial Hypercholesterolemia - Homozygous that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 13 participants. The trial reports 11 study locations across 5 states.
The verdict
NCT04659863, a Phase 3 study of Familial Hypercholesterolemia - Homozygous, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
- 11
- Study locations
Study Summary
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (11)
Other
- Novartis Investigative Site - Bron
- Metropolitan Hospital - Athens
- American University of Beirut Medical Center - Beirut
- Hotel Dieu de France Hospital - El Achrafiyé
- Novartis Investigative Site - Kuala Lumpur
- Novartis Investigative Site - Amsterdam
- Novartis Investigative Site - Izmir
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
Quebec
- Novartis Investigative Site - Québec
GR
- University General Hospital of Ioannina - Ioannina
TUR
- Novartis Investigative Site - Istanbul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04659863
The ClinicalTrials.gov registry entry for NCT04659863 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 13 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 Familial Hypercholesterolemia - Homozygous appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04659863 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Other, Florida, Quebec.
Frequently Asked Questions
What is clinical trial NCT04659863 about?
NCT04659863 is a clinical study titled "Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia". This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
What is the current status of trial NCT04659863?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2021-02-16. Estimated completion is 2024-11-18.
What conditions does trial NCT04659863 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia - Homozygous.
What interventions are being tested in trial NCT04659863?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT04659863?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04659863 being conducted?
This trial has 11 study locations across Florida, Quebec, GR, TUR. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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