- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00655265
A Study of the Safety and Efficacy of Patients With Familial Hypercholesterolaemia Taking Colesevelam as add-on Therapy to Their Existing Medication
February 10, 2014 updated by: Genzyme, a Sanofi Company
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris Cedex, France
- Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires
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Marburg, Germany
- Kardiologie
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Amsterdam, Netherlands
- Academic Medical Centre
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Nijmegen, Netherlands
- University Medical Centre
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Utrecht, Netherlands
- University Medical Centre
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Waalwijk, Netherlands
- TweeSteden Ziekenhius
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Huddinge, Sweden
- Centre for Metabolism and Endocrinology
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Manchester, United Kingdom
- Department of Medicine, University of Manchester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have a clinical diagnosis of Familial Hypercholesterolaemia defined as EITHER a.Presence of a documented LDL-receptor mutation OR b. History of untreated LDL-cholesterol level above the 95th percentile for sex and age in combination with documentation of at least one of the following: i.Presence of typical tendon xanthomas in the patient or first degree relative. ii. An LDL-cholesterol level above the 95th percentile for age and sex in a first degree relative. iii. Proven coronary artery disease in the patient or in a first degree relative under the age of 60.
- Patients must have provided and undergone lifestyle changes for more than 6 months at the time of Screening
- Patients must have been treated for at least 3 consecutive months preceding the Screening visit with a lipid lowering treatment regimen consisting of maximal tolerated combination of a statin with ezetimibe and are still above their target for LDL cholesterol being 2.5 mmol/L (100 mg/dL)
- Patients must be committed to following the protocol requirements as evidence by written informed consent
- Patients should be comfortable with swallowing 3 placebo tablets
Exclusion Criteria:
- Patients with a known allergy to any of the components used in colesevelam or placebo or any other medications like statin or ezetimibe required for participation in this study
- Patients with a bowel or biliary obstruction
- Patients with secondary causes of hypercholesterolaemia, e.g., dysproteinaemia, hypothyroidism, nephrotic syndrome (defined as proteinuria >2 g/L), obstructive liver disease, other pharmacological therapies, alcoholism
- Patients with triglyceride level of > 3.4 mmol/L
- Patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, or major gastrointestinal tract surgery
- Patients have undergone LDL-apheresis within one year prior to the screening visit and/or need to undergo LDL-apheresis
- Patients with active liver disease or unexplained persistent elevations in transaminases
- Patients on fenofibrates or on concomitant cholestyramine as this will affect the area under the curve (AUC) of ezetimibe
- Patients with poorly-controlled diabetes (i.e., HbA1c>9% at Screening)
- Patients with clinically significant (CS) abnormal haematology, renal, or other laboratory parameters that could be the result of an underlying malignancy or systemic infection as judged by the investigator
- Patients with a heart transplant, concurrent congestive heart failure (NYHA Class 3 or 4), life-threatening ventricular arrhythmias, unstable angina, recent myocardial infarction within the past 6 months prior to screening, or patients undergoing haemodialysis, or with active disease who may not be healthy enough to successfully complete all protocol requirements
- Fertile women who are pregnant, nursing or using either no or an inadequate form of contraception taking into account the recommendations for adequate intake of oral contraceptives as outlined in concomitant medication section
- Patients with a recent history of alcoholism or drug abuse, or sever emotional behavioural or psychiatric problems who may not be able to adequately comply with the requirements of the study or who may be unable to consent
- Patients receiving experimental medications or participating in another study using an experimental drug or procedure within 30 days prior to signing informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Tablets
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Experimental: Colesevelam hydrochloride film-coated tablets
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tablets
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Relative reduction in LDL cholesterol
Time Frame: Between baseline and 6 weeks DB treatment
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Between baseline and 6 weeks DB treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Relative reduction in HDL, total cholesterol, ApoA1,ApoB,ApoB/ApoA1ratio, triglycerides
Time Frame: Between Baseline and week 6 and week 12 DB treatment
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Between Baseline and week 6 and week 12 DB treatment
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Relative reduction in LDL cholesterol
Time Frame: Between Baseline and week 12 DB treatment
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Between Baseline and week 12 DB treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
April 3, 2008
First Submitted That Met QC Criteria
April 8, 2008
First Posted (Estimate)
April 9, 2008
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hypercholesterolemia
- Hyperlipoproteinemia Type II
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Colesevelam Hydrochloride
Other Study ID Numbers
- CHOL00107
- EudraCT 2007-000582-37 (Registry Identifier: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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