Study type

Study type

Clinical trial

Scope of the study

Other

If ‘other’, further details on the scope of the study

Evaluate the effects of lomitapide on carotid and aortic atherosclerosis in patients treated with lomitapide in usual clinical practice
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

LOMITAPIDE

Medical condition to be studied

Atherosclerosis prophylaxis
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

57
Study design details

Main study objective

To assess the changes in atheroma burden as reflected by average carotid vessel wall area on MRI scanning following two years of treatment with lomitapide compared to baseline

Outcomes

The primary efficacy endpoint is the percent reduction from baseline in carotid vessel wall area at the two-year evaluation. Key secondary efficacy endpoints include 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.

Data analysis plan

The primary analysis will be a one-sample t-test on the within-subject percent reduction in average carotid vessel wall area using the modified intent-to-treat (MITT) population. Descriptive statistics will also be presented, including the sample number, mean, median, standard deviation, minimum and maximum values, as well as a two-sided, 95% confidence interval. Absolute data values, including arithmetic change from baseline, will be presented descriptively, in addition to percent change from baseline. The same method of analysis as used for the primary efficacy endpoint will be used for secondary efficacy endpoints.