NCT00655265

A Study of the Safety and Efficacy of Patients With Familial Hypercholesterolaemia Taking Colesevelam as add-on Therapy to Their Existing Medication

A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, MultiCentre Study of Colesevelam as Add-on Therapy in Patients With Familial Hypercholesterolaemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess whether colesevelam given as third line treatment added to a maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.

Conditions

• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Colesevelam hydrochloride film-coated tablets	tablets
DRUG	Placebo	Tablets

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2009-10-01
• First posted: 2008-04-09
• Last updated: 2014-02-11

Locations

8 sites across 5 countries: France, Germany, Netherlands, Sweden, United Kingdom