Last reviewed · How we verify
A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, MultiCentre Study of Colesevelam as Add-on Therapy in Patients With Familial Hypercholesterolaemia
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.
Details
| Lead sponsor | Genzyme, a Sanofi Company |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 86 |
| Start date | 2007-08 |
| Completion | 2009-10 |
Conditions
- Familial Hypercholesterolemia
Interventions
- Colesevelam hydrochloride film-coated tablets
- Placebo
Primary outcomes
- Relative reduction in LDL cholesterol — Between baseline and 6 weeks DB treatment
Countries
France, Germany, Netherlands, Sweden, United Kingdom