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A randomised, double-blind, placebo-controlled, single ascending and multiple ascending dose study of the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of lomitapide in Japanese and Caucasian volunteers with elevated LDL-C

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Trial Profile

A randomised, double-blind, placebo-controlled, single ascending and multiple ascending dose study of the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of lomitapide in Japanese and Caucasian volunteers with elevated LDL-C

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Nov 2018

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At a glance

  • Drugs Lomitapide (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Aegerion Pharmaceuticals

    • Most Recent Events

    • 21 Jan 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 09 Sep 2013 Planned End Date changed from 1 Apr 2013 to 1 Dec 2013. The trial is expected to be completed in the fourth quarter of 2013 according to an Aegerion Pharmaceuticals media release.
    • 08 Jan 2013 Enrolment of Japanese volunteers was initiated in the fourth quarter of 2012, according to an Aegerion Pharmaceuticals media release.

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