The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Castle Rock, Colorado, United States
Unnamed facility
Jacksonville, Florida, United States
The percent change in LDL-C from baseline to endpoint
Time frame: 6 weeks
The absolute change in LDL-C from baseline to endpoint
Time frame: 6 weeks
The absolute and % change of total cholesterol
Time frame: 6 Weeks
The absolute and % change in triglycerides
Time frame: 6 Weeks
The absolute and % change in HDL-C
Time frame: 6 Weeks
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Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
...and 4 more locations