This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-modifying therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
459
100 mg tablet, oral, once daily for 24 weeks
Placebo tablet, orally, once daily for 24 weeks
25 mg tablet, oral, once daily for 24 weeks
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
Time frame: Baseline and Week 24
Percent Change from Baseline in HDL-C
Time frame: Baseline and Week 24
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)
Time frame: 24 Weeks
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
Time frame: 24 weeks
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)
Time frame: 24 weeks
Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
Time frame: 24 weeks
Number of Participants with Significant Increase in Blood Pressure
Time frame: 24 weeks
Percent change from Baseline in non-HDL-C
Time frame: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein B (Apo-B)
Time frame: Baseline and Week 24
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
Time frame: Baseline and Week 24
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Placebo tablet, orally, once daily for 24 weeks
Percent Change from Baseline in Lipoprotein(a) (lp[a])
Time frame: Baseline and Week 24
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal
Time frame: Baseline and Week 24