A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Atorvastatin for at Least 4 Weeks. - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00754507

Purpose

To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: colesevelam HCl tablets, and atorvastatin tablets Drug: colesevelam HCl placebo tablets and atorvastatin tablets	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of WelChol as an Add-on to Atorvastatin Therapy

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The absolute change in LDL-C from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The absolute change and % change in total cholesterol [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The absolute change and % change in triglycerides [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The absolute change and % change in HDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The absolute change and % change in C-reactive protein [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	November 2002
Study Completion Date:	April 2005
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental colesevelam tablets and atorvastatin tablets	Drug: colesevelam HCl tablets, and atorvastatin tablets colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks
2: Placebo Comparator colesevelam HCl placebo tablets and atorvastatin tablets	Drug: colesevelam HCl placebo tablets and atorvastatin tablets colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female > or greater than 18 years of age
On a stable dose of atorvastatin
LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
TG < or = to 300 mg/dL
Women are not pregnant or breast-feeding or planning to become pregnant
Women of child-bearing potential had a hysterectomy or tubal-ligation, or
women were post menopausal, or
women practiced an acceptable method of contraception as specified in the protocol

Exclusion Criteria:

BMI > 40 kg/m2
History of allergic or toxic reaction to colesevelam HCl
History of swallowing disorders
Any serious disorder that could impact the conduct of the study
History of drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754507

Locations

United States, California

Los Angeles, California, United States
United States, Colorado

Castle Rock, Colorado, United States
United States, Florida

St. Petersburg, Florida, United States

Pembroke Pines, Florida, United States

Jacksonville, Florida, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, New York

Rochester, New York, United States
United States, Ohio

Cleveland, Ohio, United States

Cincinnati, Ohio, United States
United States, Tennessee

Bartlett, Tennessee, United States
United States, Virginia

Norfolk, Virginia, United States

Richmond, Virginia, United States
United States, Washington

Seattle, Washington, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo, Inc. ( Senior Director of Metabolic Research )
Study ID Numbers:	WEL-406
Study First Received:	September 16, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00754507
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Colesevelam
Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009