Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Phase 4
Completed
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT00185107
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The percent change in LDL-C from the start of the study
- Secondary Outcome Measures
Name Time Method - 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
Trial Locations
- Locations (6)
Medical Office
🇺🇸Statesville, North Carolina, United States
Scripps Clinic
🇺🇸San Diego, California, United States
Linder Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Radiant Research
🇺🇸Edina, Minnesota, United States