Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)

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

Study Overview

• Status: Withdrawn
• Conditions: Homozygous Familial Hypercholesterolemia
• Intervention / Treatment: Drug: 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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in LOWER

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percent change from baseline in cartoid vessel wall area at the two-year evaluation	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aegerion Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Qing Chang, MD, Aegerion Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Atherosclerosis; Hyperlipoproteinemia Type II
• Other Study ID Numbers: AEGR-733-028