Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00754039

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Hyperlipidemia, Familial Combined	Drug: colesevelam HCl tablets and fenofibrate tablets Drug: fenofibrate tablets and Welchol placebo tablets	Phase IV

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Procetofen Cholest-5-en-3-ol (3beta)- Colesevelam GT31-104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

% change in LDL-C from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	129
Study Start Date:	February 2003
Study Completion Date:	March 2004
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Welchol + TriCor	Drug: colesevelam HCl tablets and fenofibrate tablets Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
2: Placebo Comparator Welchol + placebo	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

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754039

Locations

United States, Florida

Ocala, Florida, United States

Winterpark, Florida, United States

Longwood, Florida, United States
United States, Illinois

Lombard, Illinois, United States

Chicago, Illinois, United States
United States, Kansas

Overland Park, Kansas, United States
United States, North Carolina

Stateville, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Texas

San Antonio, Texas, United States
United States, Virginia

Richmond, Virginia, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo ( Senior Director, Metabolic Medical Research )
Study ID Numbers:	WEL-403
Study First Received:	September 15, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00754039
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Mixed hyperlipidemia

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hyperlipidemias
Metabolic Diseases
Colesevelam
Combined hyperlipidemia, familial
Procetofen
Metabolism, Inborn Errors

Genetic Diseases, Inborn
Hyperlipidemia, Familial Combined
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009