NCT00754039

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined

Interventions

Type	Name	Description
DRUG	colesevelam HCl tablets and fenofibrate tablets	Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
DRUG	fenofibrate tablets and Welchol placebo tablets	fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
DRUG	fenofibrate tablets and Welchol placebo tablets	fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-09-01
• Completion: 2004-03-01
• First posted: 2008-09-17
• Last updated: 2015-04-03

Locations

10 sites across 1 country: United States