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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Fenofibrate

Criteria

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.)