LOWER: Lomitapide Observational Worldwide Evaluation Registry
Amryt Pharma
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.
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment. * Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures or paediatric patients with the consent of a parent or legal guardian. Patients ≥7 years of age (or above the age determined by the IRB/EC and in accordance with the local regulations and requirements) must also provide written informed assent forms. Exclusion Criteria:…
Interventions
- DrugLomitapide
As prescribed by Physician.
Locations (75)
- Brookwood Baptist Medical CenterBirmingham, Alabama
- Springhill Physician PracticesMobile, Alabama
- Northern Arizona HealthcareCottonwood, Arizona
- One MedicalGilbert, Arizona
- Scottsdale Family HealthPhoenix, Arizona
- Pima HeartTucson, Arizona