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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Daiichi Sankyo Inc.

Current Primary Outcome: % change in LDL-C from baseline [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The absolute change in LDL-C from baseline [ Time Frame: 6 weeks ]
  • The absolute change and % change in LDL-C from week -8 (untreated) [ Time Frame: 14 weeks ]
  • The percentage of patients who achieved target LDL-C [ Time Frame: 6 Weeks ]


Original Secondary Outcome: Same as current

Information By: Daiichi Sankyo Inc.

Dates:
Date Received: September 15, 2008
Date Started: February 2003
Date Completion:
Last Updated: April 2, 2015
Last Verified: April 2015