Study Complete
Sponsor ID
20101154
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid levelsMENDEL
Study Details
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with
hypercholesterolemia.
Protocol Summary
Primary Outcome Measures
Percent change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment
Timeframe: 12 weeks
Secondary Outcome Measures
Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment
Timeframe: 12 weeks
Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) after 12 weeks of treatment
Timeframe: 12 weeks
Percent change from baseline in apolipoprotein B (ApoB) after 12 weeks of treatment
Timeframe: 12 weeks
Percent change from baseline in the total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio after 12 weeks of treatment
Timeframe: 12 weeks
Percent change from baseline in apolipoprotein B/apolipoprotein A1 (ApoB/ApoA1) ratio after 12 weeks of treatment
Timeframe: 12 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Maroubra, NSW, Australia, 2035
Status
Recruiting
Location
Research Site
Carina Heights, QLD, Australia, 4152
Status
Completed
Location
Research Site
Ham, Belgium, 3945
Status
Completed
Location
Research Site
Halen, Belgium, 3545
Status
Completed
Location
Research Site
Dour, Belgium, 7370
Status
Completed
Location
Research Site
Gozee, Belgium, 6534
Status
Completed
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