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Inclisiran for High Cholesterol (V-PEDS-OLE Trial)
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.
V-PEDS-OLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 482 Patients • NCT03397121V-PEDS-OLE Trial Design
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Who is running the clinical trial?
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- People who were part of the ORION-16 or ORION-13 studies and have been diagnosed with HeFH or HoFH.I was previously in ORION-16 or ORION-13 studies but had to stop due to serious side effects or other reasons.Your doctor believes that you benefited from taking inclisiran in the ORION-16 or ORION-13 studies.
- Group 1: Inclisiran
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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