Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Aegerion Pharmaceuticals

Status: Withdrawn

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Drug: Lomitapide

Study type: Observational

Funder types: Industry

Identifiers

NCT02399852

AEGR-733-028

Details and patient eligibility

About

Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

Full description

This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (age ≥18 years) who are enrolled in LOWER

Exclusion criteria

• Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
• Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
• Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
• Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
• Patients with an implanted insulin pump
• Patients with metal shrapnel or bullet wounds
• Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)
• Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)