LOWER: Lomitapide Observational Worldwide Evaluation Registry

Completed

Conditions studied: Homozygous Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT02135705

Run by

Amryt Pharma

People needed

260

Starts

2014-03-18

Expected to finish

2026-04-27

Last updated by the study team

2026-05-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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..

Where it is running

• Springhill Physician Practices — Mobile, Alabama, United States
• Northern Arizona Healthcare — Cottonwood, Arizona, United States
• Scottsdale Family Health — Phoenix, Arizona, United States
• Pima Heart — Tucson, Arizona, United States
• Arkansas Heart Center — Fort Smith, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Colorado Health — Aurora, Colorado, United States
• Alfieri Cardiology — Newark, Delaware, United States
• Preventative Cardiology, Inc. — Boca Raton, Florida, United States
• Florida Lipid Institute — Winter Park, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Atlanta Heart Specialists — Cumming, Georgia, United States
• Northside Hospital, Inc. — Cumming, Georgia, United States
• Comprehensive Cardiovascular Care — Gurnee, Illinois, United States
• Community Health Network — Indianapolis, Indiana, United States
• St. Vincent Medical Group, Inc. — Indianapolis, Indiana, United States
• Henry County Medical Center — New Castle, Kentucky, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Get Well Immediate Care — Towson, Maryland, United States
• Complete Family Care Cholesterol Treatment Center — Sterling Heights, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• HealthEast Care System — Saint Paul, Minnesota, United States
• Stern Cardiovascular Foundation — Southaven, Mississippi, United States
• Methodist Physicians Clinic — Omaha, Nebraska, United States
• Brookwood Baptist Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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