This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Placebo once daily for 8 weeks
Atorvastatin 10mg once daily for 8 weeks
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Richmond, Virginia, United States
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Time frame: 8 weeks
Percent change in LDL-C
Time frame: 2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors
Time frame: 2, 4, 6 and 8 weeks
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