- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754507
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks.
April 2, 2015 updated by: Daiichi Sankyo, Inc.
Efficacy of WelChol as an Add-on to Atorvastatin Therapy
To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
65
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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California
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Los Angeles, California, United States
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Colorado
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Castle Rock, Colorado, United States
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Florida
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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St. Petersburg, Florida, United States
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Indiana
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Indianapolis, Indiana, United States
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New York
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Rochester, New York, United States
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Ohio
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Tennessee
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Bartlett, Tennessee, United States
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Virginia
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Washington
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Seattle, Washington, United States
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female > or greater than 18 years of age
- On a stable dose of atorvastatin
- LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
- TG < or = to 300 mg/dL
- Women are not pregnant or breast-feeding or planning to become pregnant
- Women of child-bearing potential had a hysterectomy or tubal-ligation, or
- women were post menopausal, or
- women practiced an acceptable method of contraception as specified in the protocol
Exclusion Criteria:
- BMI > 40 kg/m2
- History of allergic or toxic reaction to colesevelam HCl
- History of swallowing disorders
- Any serious disorder that could impact the conduct of the study
- History of drug or alcohol abuse
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
colesevelam tablets and atorvastatin tablets
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colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks
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Placebo Comparator: 2
colesevelam HCl placebo tablets and atorvastatin tablets
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colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.
Time Frame: 6 weeks
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The absolute change in LDL-C from baseline to endpoint
Time Frame: 6 weeks
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6 weeks
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The absolute change and % change in total cholesterol
Time Frame: 6 Weeks
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6 Weeks
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The absolute change and % change in triglycerides
Time Frame: 6 Weeks
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6 Weeks
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The absolute change and % change in HDL-C
Time Frame: 6 Weeks
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6 Weeks
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The absolute change and % change in C-reactive protein
Time Frame: 6 weeks
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6 weeks
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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
November 1, 2002
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
September 16, 2008
First Submitted That Met QC Criteria
September 16, 2008
First Posted (Estimate)
September 18, 2008
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 2, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Colesevelam Hydrochloride
Other Study ID Numbers
- WEL-406
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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