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Trial record 10 of 18 for:    lomitapide

Effects of Lomitapide on Carotid and Aortic Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399852
Recruitment Status : Withdrawn
First Posted : March 26, 2015
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Lomitapide


Intervention Details:
  • Drug: Lomitapide
    Other Names:
    • Juxtapid
    • Lojuxta


Primary Outcome Measures :
  1. The percent change from baseline in cartoid vessel wall area at the two-year evaluation [ Time Frame: 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. [ Time Frame: 5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in LOWER
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399852


Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Qing Chang, MD Aegerion Pharmaceuticals, Inc.

Additional Information:

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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02399852    
Other Study ID Numbers: AEGR-733-028
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: March 2015
Additional relevant MeSH terms:
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Atherosclerosis
Hyperlipoproteinemia Type II
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias