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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00655265 |
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.
Condition | Intervention | Phase |
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Familial Hypercholesterolemia |
Drug: Colesevelam hydrochloride film-coated tablets Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, MultiCentre Study of Colesevelam as Add-on Therapy in Patients With Familial Hypercholesterolaemia |
Enrollment: | 86 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Colesevelam hydrochloride film-coated tablets
tablets
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2: Placebo Comparator |
Drug: Placebo
Tablets
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires | |
Paris Cedex, France | |
Germany | |
Kardiologie | |
Marburg, Germany | |
Netherlands | |
Academic Medical Centre | |
Amsterdam, Netherlands | |
University Medical Centre | |
Nijmegen, Netherlands | |
TweeSteden Ziekenhius | |
Waalwijk, Netherlands | |
University Medical Centre | |
Utrecht, Netherlands | |
Sweden | |
Centre for Metabolism and Endocrinology | |
Huddinge, Sweden | |
United Kingdom | |
Department of Medicine, University of Manchester | |
Manchester, United Kingdom |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Coporation ( Medical Monitor ) |
Study ID Numbers: | CHOL00107, EudraCT 2007-000582-37 |
Study First Received: | April 3, 2008 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00655265 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency |
Antimetabolites Lipid Metabolism, Inborn Errors Hyperlipidemias Metabolic Diseases Colesevelam Antilipemic Agents Hyperlipoproteinemia Type II Anticholesteremic Agents |
Metabolism, Inborn Errors Genetic Diseases, Inborn Hypercholesterolemia, Autosomal Dominant Hypercholesterolemia Metabolic Disorder Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Lipid Metabolism, Inborn Errors Hyperlipidemias Metabolic Diseases Colesevelam Molecular Mechanisms of Pharmacological Action Antilipemic Agents Hyperlipoproteinemia Type II Anticholesteremic Agents |
Pharmacologic Actions Metabolism, Inborn Errors Genetic Diseases, Inborn Therapeutic Uses Hypercholesterolemia Dyslipidemias Hyperlipoproteinemias Lipid Metabolism Disorders |