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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02399852

Enrollment

Registered

2015-03-26

Start date

2015-06-30

Completion date

2021-12-31

Last updated

2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homozygous Familial Hypercholesterolemia

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.

Interventions

DRUGLomitapide

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026