Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
NCT ID: NCT00754039
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
129 participants
INTERVENTIONAL
2003-02-28
2004-03-31
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
TRIPLE
Study Groups
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1
Welchol + TriCor
colesevelam HCl tablets and fenofibrate tablets
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
2
Welchol + placebo
fenofibrate tablets and Welchol placebo tablets
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
fenofibrate tablets and Welchol placebo tablets
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
Interventions
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colesevelam HCl tablets and fenofibrate tablets
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
fenofibrate tablets and Welchol placebo tablets
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
fenofibrate tablets and Welchol placebo tablets
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
Eligibility Criteria
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Inclusion Criteria
* History of mixed hyperlipidemia
* Prescribed a Step 1 diet at least 30 days prior to screening
* Women were not pregnant, breast-feeding, or plan to become pregnant during the study
* Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
* Serum LDL-C \>/= 115 mg/dL; Serum TG \>/= 150 \& \< 750 mg/dL
Exclusion Criteria
* HbA1C \> 10%
* Type 1 diabetes
* Intolerance to fibrates
* History of intolerance to colesevelam HCl
* History of swallowing disorders or intestinal motility disorders
* Any other disorder that might interfere with the conduct of the study
* History of drug or alcohol abuse
* Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)
30 Years
70 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo
Locations
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Longwood, Florida, United States
Ocala, Florida, United States
Winterpark, Florida, United States
Chicago, Illinois, United States
Lombard, Illinois, United States
Overland Park, Kansas, United States
Stateville, North Carolina, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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WEL-403
Identifier Type: -
Identifier Source: org_study_id
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