Effects of Lomitapide on Carotid and Aortic Atherosclerosis

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02399852
• Other study ID #: AEGR-733-028
• Status: Withdrawn
• Phase: N/A
• First received: March 23, 2015
• Last updated: December 13, 2017
• Start date: June 2015
• Est. completion date: December 2021

Study information

• Verified date: March 2015
• Source: Aegerion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atherosclerosis
• Homozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Lomitapide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aegerion Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change from baseline in cartoid vessel wall area at the two-year evaluation		2 years
Secondary	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