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NCT06597019 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
A Phase 3 study of Familial Hypercholesterolemia - Heterozygous, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT06597019 is a Phase 3 study of Familial Hypercholesterolemia - Heterozygous that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 51 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT06597019, a Phase 3 study of Familial Hypercholesterolemia - Heterozygous, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Salzburg
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Leuven
California
- UC San Francisco Medical Center - San Francisco
- UC San Francisco Medical Center - San Francisco
District of Columbia
- Children's National Hospital - Washington D.C.
- Childrens National Hospital - Washington D.C.
Utah
- Primary Childrens Medical Center - Salt Lake City
- Primary Childrens Medical Center - Salt Lake City
West Virginia
- West Virginia Childrens Hospital - Morgantown
- West Virginia Childrens Hospital - Morgantown
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
New York
- Icahn School of Med at Mt Sinai - New York
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2029-04-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06597019
The ClinicalTrials.gov registry entry for NCT06597019 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 51 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 - Heterozygous appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06597019 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06597019 about?
NCT06597019 is a clinical study titled "Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia". This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
What is the current status of trial NCT06597019?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2024-12-09. Estimated completion is 2029-04-15.
What conditions does trial NCT06597019 study?
This clinical trial studies the following conditions: Familial Hypercholesterolemia - Heterozygous.
What interventions are being tested in trial NCT06597019?
The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).
Who is sponsoring clinical trial NCT06597019?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597019 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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