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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02399852
Other study ID # AEGR-733-028
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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)

Study Design


Related Conditions & MeSH terms


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
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