Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

Study Overview
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Brief Summary
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The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.

Official Title
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The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Conditions
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Hypercholesterolemia, Hyperlipidemia, Familial Combined

Intervention / Treatment
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* Drug: colesevelam HCl tablets and fenofibrate tablets
* Drug: fenofibrate tablets and Welchol placebo tablets
* Drug: fenofibrate tablets and Welchol placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30-70 years of age 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: BMI >40 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.)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Welchol + TriCor | Drug: colesevelam HCl tablets and fenofibrate tablets<br>* Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day<br>|
| Placebo Comparator: 2<br>Welchol + placebo | Drug: fenofibrate tablets and Welchol placebo tablets<br>* fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day<br>Drug: fenofibrate tablets and Welchol placebo tablets<br>* fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in LDL-C from baseline |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in LDL-C from baseline |  | 6 weeks | 
| The absolute change and % change in LDL-C from week -8 (untreated) |  | 14 weeks | 
| The percentage of patients who achieved target LDL-C |  | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed hyperlipidemia