Hypercholesterolemia
Conditions
Keywords
Safety, Efficacy, WelChol®, Zocor®, Zetia®
Brief summary
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
Interventions
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change in LDL-C from the start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
United States
Outcome results
None listed