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

2014-07-24 14:18:08 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Familial Hypercholesterolemia

Intervention

Colesevelam hydrochloride film-coated tablets, Placebo

Location

Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires
Paris Cedex
France

Status

Completed

Source

Genzyme

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:18:08-0400

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Cholesterol
Cholesterol is a waxy steroid metabolite found in the cell membranes and transported in the blood plasma. It is an important structural component of mammalian cell membranes, where it is establishes proper membrane permeability and fluidity. Cholesterol ...


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