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

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00754039

First received: September 15, 2008

Last updated: September 16, 2008

Last verified: September 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 15, 2008
Last Updated Date	September 16, 2008
Start Date ^ICMJE	February 2003
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 16, 2008)	% change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00754039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 16, 2008)	The absolute change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] The absolute change and % change in LDL-C from week -8 (untreated) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ] The percentage of patients who achieved target LDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Hypercholesterolemia Hyperlipidemia, Familial Combined
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Welchol + TriCor Intervention: Drug: colesevelam HCl tablets and fenofibrate tablets Placebo Comparator: 2 Welchol + placebo Interventions: Drug: fenofibrate tablets and Welchol placebo tablets Drug: fenofibrate tablets and Welchol placebo tablets
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	129
Completion Date	March 2004
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.)
Gender	Both
Ages	30 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00754039
Other Study ID Numbers ^ICMJE	WEL-403
Has Data Monitoring Committee	No
Responsible Party	Senior Director, Metabolic Medical Research, Daiichi Sankyo
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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