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
Phase of Trial: Phase I
Latest Information Update: 17 May 2014
At a glance
- Drugs Lomitapide (Primary)
- Indications Hyperlipoproteinaemia type IIa
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Aegerion Pharmaceuticals
- 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.