Study Complete
Sponsor ID
20110109
Durable Effect of PCSK9 antibody CompARed wiTh placEbo StudyDESCARTES
Study Details
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
Protocol Summary
Primary Outcome Measures
Percent change from baseline in LDL-C at week 52
Timeframe: 52 weeks
Secondary Outcome Measures
Percent change from baseline in LDL-C at week 12
Timeframe: 12 weeks
Percent change from week 12 in LDL-C at week 52
Timeframe: 40 weeks
Absolute change from baseline in LDL-C at week 52
Timeframe: 52 weeks
Percent change from baseline in non-HDL-C at week 52
Timeframe: 52 weeks
Percent change from baseline in ApoB at week 52
Timeframe: 52 weeks
Percent change from baseline in the total cholesterol/HDL-C ratio at week 52
Timeframe: 52 weeks
Percent change from baseline in ApoB/ApoA1 ratio at week 52
Timeframe: 52 weeks
LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52
Timeframe: 52 weeks
Percent change from baseline in TC at week 12
Timeframe: 12 weeks
Percent change from baseline in TC at week 52
Timeframe: 52 weeks
Percent change from baseline in Lp(a) at week 52
Timeframe: 52 weeks
Percent change from baseline in triglycerides at week 52
Timeframe: 52 weeks
Percent change from baseline in HDL-C at week 52
Timeframe: 52 weeks
Percent change from baseline in VLDL-C at week 52
Timeframe: 52 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Toronto, ON, Canada, M9W 4L6
Status
Completed
Location
Research Site
Newmarket, ON, Canada, L3Y 5G8
Status
Completed
Location
Research Site
Sudbury, ON, Canada, P3C 5K7
Status
Completed
Location
Research Site
Louisville, KY, United States, 40213
Status
Recruiting
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Fargo, ND, United States, 58103
Status
Recruiting
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