LOWER: Lomitapide Observational Worldwide Evaluation Registry (v6.0)
Research type
Research Study
Full title
Lomitapide Observational Worldwide Evaluation Registry
IRAS ID
227605
Contact name
Peter Ksenuk
Contact email
Sponsor organisation
Aegerion Pharmaceuticals, Inc
Clinicaltrials.gov Identifier
ENCEPP/SDPP/5326, EU PAS register number; H0002578, Product reference; EU: H/C002578/0000, Procedure number
Duration of Study in the UK
12 years, 9 months, 20 days
Research summary
Lomitapide is a drug that has been approved to treat people who suffer from Homozygous Familial Hypercholesterolemia. Lomitapide was approved as
Juxtapid®in the United States on December 21, 2012 and as Lojuxta® in the
European Union on July 31, 2013. The registry is being conducted at the request of the FDA and the European Committee for Medicinal Products for Human Use as a post-marketing commitment and a Condition of Market Authorisation, respectively.
This registry is requested as there is a need for information from clinical practice to establish the long term safety profile of the product as well as to help characterize the effectiveness of lomitapide and patterns of use in actual practice, and to assess risk minimisation interventions in place for the product.
The observational registry will be global and estimated to include at least 300 adult patients treated with lomitapide who agree to participate in the study. In non-EU countries, the registry will continue for 10 years from the date that the 300th patient is enrolled. In the EU, the registry will remain open indefinitely. Patients will be recruited from sites where they are treated by their physician. Patients who are over 18 years of age who received lomitapide at enrolment or within 15 months prior to enrolment will be approached regarding entering this study.REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0590
Date of REC Opinion
17 Oct 2017
REC opinion
Favourable Opinion