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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00753779

Purpose

The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin 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 Simvastatin Therapy

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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 and % change of total cholesterol [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The absolute and % change in triglycerides [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
The absolute and % change in HDL-C [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment:	72
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 HCl Tablets and simvastatin tablets	Drug: colesevelam HCl tablets, and simvastatin tablets colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
2: Placebo Comparator simvastatin and Welchol placebo	Drug: simvastatin tablets and colesevelam HCl placebo simvastatin tablet, 1/day; Welchol placebo tablets, 6/day

Eligibility

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

Criteria

Inclusion Criteria:

Males or females
> or = to 18 years of age
On a stable dose of simvastatin for 4 or more weeks
LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
TG < 300 mg/dL
Women are not pregnant or breast-feeding or planning to become pregnant
Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception

Exclusion Criteria:

BMI > 40
Allergic to colesevelam HCl
History of swallowing disorder
History of gastrointestinal motility disorder
Any disorder that might interfere with the study
History of drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753779

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, Illinois

Chicago, Illinois, 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

No publications provided

Responsible Party:	Daiichi Sankyo, Inc. ( Senior Director Metobolic Research )
Study ID Numbers:	WEL-405
Study First Received:	September 16, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00753779 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Colesevelam
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Colesevelam
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009