Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4GAUSS-4
Study Details
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin.
Protocol Summary
Mean percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Timeframe: 10 and 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Timeframe: 12 Weeks
Mean change from baseline in low density lipoprotein-cholesterol (LDL-C)
Timeframe: 10 and 12 Weeks
Change from baseline in low density lipoprotein-cholesterol (LDL-C)
Timeframe: 12 Weeks
Mean low density lipoprotein-cholesterol response (LDL-C < 70 mg/dL [1.8 mol/L])
Timeframe: 10 and 12 Weeks
Low density lipoprotein-cholesterol response (LDL-C < 70 mg/dL [1.8 mmol/L])
Timeframe: 12 Weeks
Mean percent change from baseline in total cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in total cholesterol
Timeframe: 12 Weeks
Mean percent change from baseline in non-high density lipoprotein-cholesterol (HDL-C)
Timeframe: 10 and 12 Weeks
Percent change from baseline in non-HDL-C
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B (ApoB)
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B (ApoB)
Timeframe: 12 Weeks
Mean percent change from baseline in the total cholesterol/high density lipoprotein- cholesterol (HDL-C) ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in the total cholesterol/high density lipoprotein- cholesterol (HDL-C) ratio
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B (ApoB)/apolipoprotein A1 (ApoA1) ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B (ApoB)/apolipoprotein A1 (ApoA1) ratio
Timeframe: 12 Weeks
Mean percent change from baseline in lipoprotein a [Lp(a)]
Timeframe: 10 and 12 Weeks
Percent change from baseline in lipoprotein a [Lp(a)]
Timeframe: 12 Weeks
Mean percent change from baseline in triglycerides
Timeframe: 10 and 12 Weeks
Percent change from baseline in triglycerides
Timeframe: 12 Weeks
Mean percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Timeframe: 10 and 12 Weeks
Percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Timeframe: 12 Weeks
Mean percent change from baseline in very low density lipoprotein-cholesterol (VLDL-C)
Timeframe: 10 and 12 Weeks
Percent change from baseline in very low density lipoprotein-cholesterol (VLDL-C)
Timeframe: 12 Weeks