Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Colesevelam Hydrochloride (Drug); Ezetimibe (Drug); Simvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
Summary
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The percent change in LDL-C from the start of the study
Secondary outcome: - 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Scripps Clinic, San Diego, California 92128, United States
Renstar Medical Research, Ocala, Florida 34471, United States
Radiant Research, Overland Park, Kansas 66215, United States
L-MARC Research Center, Louisville, Kentucky 40213, United States
Radiant Research, Edina, Minnesota 55435, United States
Medical Office, Statesville, North Carolina 28677, United States
Linder Clinical Trial Center, Cincinnati, Ohio 45219, United States
Additional Information
Starting date: March 2005
Ending date: October 2005
Last updated: September 10, 2007
|
