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

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

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.

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.)