Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 10:09 PM
Study NCT ID:
NCT02135705
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOWER: Lomitapide Observational Worldwide Evaluation Registry
Sponsor:
Amryt Pharma
Organization:
Study Overview
Official Title:
LOWER: Lomitapide Observational Worldwide Evaluation Registry
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOWER
Brief 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.
Detailed Description:
To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: