Effects of Lomitapide on Carotid and Aortic Atherosclerosis

NCT02399852 | Withdrawn DMC

• 1 other identifier: AEGR-733-028
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The percent change from baseline in cartoid vessel wall area at the two-year evaluation

  2 years

Secondary Outcomes (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

Interventions

Lomitapide DRUG

Also known as: Juxtapid, Lojuxta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in LOWER

You may qualify if:

• Adult patients (age ≥18 years) who are enrolled in LOWER

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aegerion Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

BMS201038

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type II; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Qing Chang, MD

  Aegerion Pharmaceuticals, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: December 15, 2017

Record last verified: 2015-03