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Clinical Trial Summary

Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

- To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.

- To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.


Clinical Trial Description

Total duration of the study per subject (excluding screening) is about 22 weeks. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01723735
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date November 2012
Completion date July 2013

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