Effects of Lomitapide on Carotid and Aortic Atherosclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02399852
• Date of registration: 23/03/2015
• Prospective Registration: Yes
• Primary sponsor: Aegerion Pharmaceuticals, Inc.
• Public title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis
• Scientific title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
• Date of first enrolment: June 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02399852
• Study type: Observational [Patient Registry]
• Phase: N/A

Contacts

• Name: Qing Chang, MD
• Affiliation: Aegerion Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Homozygous Familial Hypercholesterolemia

Intervention(s)

Drug: Lomitapide

Primary Outcome(s)

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

Secondary Outcome(s)

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. [Time Frame: 5 Years]

Secondary ID(s)

AEGR-733-028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors