LOWER: Lomitapide Observational Worldwide Evaluation Registry

Launched by AMRYT PHARMA · May 8, 2014

Keywords

ClinConnect Summary

The LOWER study is looking at the long-term safety and effectiveness of a medication called lomitapide for patients with a rare genetic condition known as Homozygous Familial Hypercholesterolemia, which causes very high cholesterol levels. This is a global study where researchers will monitor patients who are already taking lomitapide to help understand how well it works over time and to ensure it is safe for them.

To participate in this study, patients of all ages can join as long as they have started treatment with lomitapide. This includes children, who will need their parent or guardian's permission. However, people currently involved in other clinical trials or taking other experimental medications cannot join. Participants will be asked to provide information about their health and treatment experiences, and this will help guide future care for others with similar conditions. If you or a loved one is considering joining, it could be an important opportunity to contribute to valuable research while receiving ongoing treatment.

Gender

ALL

Eligibility criteria

• 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:
• • Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
• • Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received market authorization in the country of participation, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. These patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..