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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Recruitment Status : Withdrawn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.

Tracking Information
First Submitted Date March 23, 2015
First Posted Date March 26, 2015
Last Update Posted Date December 15, 2017
Study Start Date June 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2015)
The percent change from baseline in cartoid vessel wall area at the two-year evaluation [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2015)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Lomitapide on Carotid and Aortic Atherosclerosis
Official Title Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
Brief Summary Study to assess changes in carotid and aortic atherosclerosis in patients being treated with 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients enrolled in LOWER
Condition Homozygous Familial Hypercholesterolemia
Intervention Drug: Lomitapide
Other Names:
  • Juxtapid
  • Lojuxta
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: December 13, 2017)
0
Original Estimated Enrollment
 (submitted: March 25, 2015)
57
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02399852
Other Study ID Numbers AEGR-733-028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Aegerion Pharmaceuticals, Inc.
Study Sponsor Aegerion Pharmaceuticals, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Qing Chang, MD Aegerion Pharmaceuticals, Inc.
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date March 2015