Effects of Lomitapide on Carotid and Aortic Atherosclerosis

• Sponsor: Aegerion Pharmaceuticals, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT02399852
• Collaborator: (none)
• Enrollment: 0
• Duration (Months): 78

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Homozygous Familial Hypercholesterolemia	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 0 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
• Study Start Date: Jun 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. The percent change from baseline in cartoid vessel wall area at the two-year evaluation [2 years]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aegerion Pharmaceuticals, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aegerion Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02399852
• Other Study ID Numbers: AEGR-733-028
• First Posted: Mar 26, 2015
• Last Update Posted: Dec 15, 2017
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Atherosclerosis; Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

No Results Posted as of Dec 15, 2017