Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Withdrawn

• Conditions: Homozygous Familial Hypercholesterolemia

• Registration Number: NCT02399852
• Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Study Start: 2015-06
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15
• Primary Completion: 2018-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percent change from baseline in cartoid vessel wall area at the two-year evaluation	2 years

Secondary Outcome Measures

Name	Time	Method
The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness.	5 Years