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siRNA

Inclisiran for High Cholesterol (V-PEDS-OLE Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 in the study up to the end of study visit; up to 1080 days
Awards & highlights

V-PEDS-OLE Trial Summary

This trial studies the long-term safety and effectiveness of a drug for people with high cholesterol due to familial hypercholesterolemia.

Who is the study for?
This trial is for men and women who have a condition called HeFH or HoFH, which are types of high cholesterol, and have already been part of the ORION-16 or ORION-13 studies. They should have seen benefits from taking inclisiran previously without serious safety issues.Check my eligibility
What is being tested?
The study is testing the long-term safety and how well people can tolerate inclisiran, a medication for lowering cholesterol levels in patients with HeFH or HoFH who completed prior related studies.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any long-term safety concerns and how well they can handle inclisiran over an extended period.

V-PEDS-OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 in the study up to the end of study visit; up to 1080 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 in the study up to the end of study visit; up to 1080 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Secondary outcome measures
Percentage and absolute change in LDL-C from baseline in the feeder study to end of study

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121
12%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Inclisiran

V-PEDS-OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: InclisiranExperimental Treatment1 Intervention
Inclisiran sodium 300mg (equivalent to 284mg inclisiran*) in 1.5mL solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,580 Total Patients Enrolled
18 Trials studying Hypercholesterolemia
12,169 Patients Enrolled for Hypercholesterolemia

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT05682378 — Phase 3
Hypercholesterolemia Research Study Groups: Inclisiran
Hypercholesterolemia Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT05682378 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05682378 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of risks are associated with Inclisiran's use as a treatment?

"Data collected from Phase 3 trials indicate that Inclisiran is a safe and effective treatment, resulting in it receiving the maximum score of three on our safety scale."

Answered by AI

Are there any remaining slots in this research program for participants?

"As indicated on clinicaltrials.gov, the search for participants is ongoing. This research study was released to the public on February 10th of 2023 and underwent its latest edit on March 28th of 2023."

Answered by AI

How many volunteers are actively engaged in this clinical trial?

"Yes, according to clinicaltrials.gov the trial is presently open for enrollment and seeking 165 patients across 3 sites. The initial post was published on February 10th 2023 with a most recent update occurring March 28th 2023."

Answered by AI
~110 spots leftby Dec 2027