RecruitingNCT02135705
LOWER: Lomitapide Observational Worldwide Evaluation Registry
Sponsor
Amryt Pharma
Enrollment
300 participants
Start Date
Mar 18, 2014
Study Type
OBSERVATIONAL
Conditions
Summary
This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
Eligibility
Plain Language Summary
Simplified for easier understanding
LOWER is a worldwide registry study that tracks patients treated with lomitapide — a medication used to lower very high cholesterol levels in people with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition causing dangerously elevated LDL cholesterol. The registry collects real-world safety and effectiveness data over many years.
You may be eligible if:
- You are a patient of any age (including minors) who has started commercial treatment with lomitapide
- You are able to understand the study requirements and provide (or have a guardian provide) written informed consent
You may NOT be eligible if:
- You are receiving lomitapide in the context of a separate clinical trial or compassionate use program with its own data collection protocol
- You are currently receiving another investigational (unapproved) drug at the time you start lomitapide and are still receiving it at enrollment (you may enroll once that other drug is stopped)
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGLomitapide
As prescribed by Physician.
Locations(75)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02135705
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