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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185107
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 11, 2007
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Colesevelam Hydrochloride Drug: Ezetimibe Drug: Simvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2005
Study Completion Date : October 2005

Primary Outcome Measures :
  1. The percent change in LDL-C from the start of the study

Secondary Outcome Measures :
  1. - The absolute change in LDL-C from baseline
  2. - The percent change in LDL-C from baseline
  3. - The absolute changes and percent changes in TG, non-HDL-
  4. C, HDL-C, total cholesterol and other lipid measures
  5. - The percentages of patients who achieve target levels of LDL-C at the end of the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185107

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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.
Layout table for additonal information Identifier: NCT00185107    
Other Study ID Numbers: WEL-408
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007
Keywords provided by Daiichi Sankyo, Inc.:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors