Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

This study has been completed.

First Received: September 9, 2005 Last Updated: September 10, 2007 History of Changes

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00185107

Purpose

Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Colesevelam Hydrochloride Drug: Ezetimibe Drug: Simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe Colesevelam GT31-104

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

The percent change in LDL-C from the start of the study

Secondary Outcome Measures:

- The absolute change in LDL-C from baseline
- The percent change in LDL-C from baseline
- The absolute changes and percent changes in TG, non-HDL-
C, HDL-C, total cholesterol and other lipid measures
- The percentages of patients who achieve target levels of LDL-C at the end of the study

Estimated Enrollment:	45
Study Start Date:	March 2005
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-80 years of age, inclusive;
A history of primary hypercholesterolemia

Exclusion Criteria:

Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185107

Locations

United States, California
Scripps Clinic
San Diego, California, United States, 92128
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66215
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, North Carolina
Medical Office
Statesville, North Carolina, United States, 28677
United States, Ohio
Linder Clinical Trial Center
Cincinnati, Ohio, United States, 45219

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Study ID Numbers:	WEL-408
Study First Received:	September 9, 2005
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00185107 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Safety
Efficacy
WelChol®
Zocor®
Zetia®

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010