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NCT05763875 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
A Phase 3 study of Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT05763875: Completed Phase 3 study of Hypercholesterolemia, sponsored by Novartis Pharmaceuticals.
NCT05763875 is a Phase 3 study of Hypercholesterolemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 350 participants, below the 811-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05763875, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.
Primary Outcome
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permane
Conditions Studied
Interventions
- DRUG Ezetimibe
- DRUG Inclisiran
- DRUG Matching Placebo for Inclisiran
- DRUG Matching Placebo for Ezetimibe
Study Locations (20)
Florida
- Hillcrest Medical Research - DeLand
- ClinCloud - Maitland
- Alma Clinical Research Inc - Miami
- Inpatient Research Clinical LLC - Miami Lakes
- Harmony Clinical Research - North Miami Beach
- Fam Medical Specialists Of Fl Plc - Plant City
- Cozy Research LLC - Zephyrhills
Louisiana
- Grace Research LLC - Bossier City
- Grace Research Llc - Shreveport
- Southern Clin Research Clinic - Zachary
Alabama
- Parkway Medical Center - Birmingham
- SEC Clinical Research - Dothan
Illinois
- Koch Family Medicine - Morton
New York
- Prime Global Research Inc - The Bronx
North Carolina
- Monroe Biomedical Research - Monroe
North Dakota
- Lillestol Research LLC - Fargo
Ohio
- WellNow Urgent Care and Research - Huber Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2024-06-20 |
| Phase | Phase 3 |
What the finished NCT05763875 record still lists
NCT05763875 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 811-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 4 interventions - of which Ezetimibe is the first listed.
NCT05763875 names 20 study sites across 11 states, led by Florida, Louisiana, Alabama.
Frequently Asked Questions
What is clinical trial NCT05763875 about?
NCT05763875 is a clinical study titled "Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.". CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was conducted in eligible participan...
What is the current status of trial NCT05763875?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2023-03-15. Estimated completion is 2024-06-20.
What conditions does trial NCT05763875 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT05763875?
The interventions under investigation include: Ezetimibe (DRUG), Inclisiran (DRUG), Matching Placebo for Inclisiran (DRUG), Matching Placebo for Ezetimibe (DRUG).
Who is sponsoring clinical trial NCT05763875?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05763875 being conducted?
This trial has 20 study locations across Alabama, Florida, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05763875's enrollment target sits among peer trials
350 23rd of 62 higher than 40 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia 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.
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