Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Homozygous Familial Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lomitapide

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Juxtapid Lojuxta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qing Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Aegerion Pharmaceuticals, Inc.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AEGR-733-028

Identifier Type: -

Identifier Source: org_study_id