A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Pravastatin for at Least 4 Weeks.
NCT ID: NCT00755352
Last Updated: 2015-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2002-11-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
pravastatin tablets and Welchol tablets
pravastatin tablets and Welchol tablets
pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
2
pravastatin tablets and Welchol placebo tablets
pravastatin tablets and Welchol placebo tablets
pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day
Interventions
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pravastatin tablets and Welchol tablets
pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
pravastatin tablets and Welchol placebo tablets
pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day
Eligibility Criteria
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Inclusion Criteria
* On a stable dose of pravastatin
* LDL-C \> or = to 100 mg/dL and \< or = 250 mg/dL
* Triglycerides \< or = to 300 mg/dL
* Women are not pregnant or breast-feeding or planning to become pregnant
* Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control as specified in the protocol
Exclusion Criteria
* History of allergic or toxic reaction to colesevelam HCL
* History of swallowing disorder
* Any serious condition that would interfere with the conduct of the study
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Castle Rock, Colorado, United States
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Bartlett, Tennessee, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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WEL-407
Identifier Type: -
Identifier Source: org_study_id
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