Reduction of LDL-C with PCSK9 inhibition in heterozygous familial hypercholesterolemia disorder study-2RUTHERFORD-2
Study Details
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W)
and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).
Protocol Summary
Mean percent change from baseline in low density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean change from baseline in low density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Change from baseline in low density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
Timeframe: 10 and 12 Weeks
Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
Timeframe: 12 Weeks
Mean percent change from baseline in non-high density lipoprotein-cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in non-high density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B
Timeframe: 12 Weeks
Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
Timeframe: 12 Weeks
Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
Timeframe: 10 and 12 Weeks
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
Timeframe: 12 Weeks
Mean percent change from baseline in lipoprotein (a)
Timeframe: 10 and 12 Weeks
Percent change from baseline in lipoprotein (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
Timeframe: 10 and 12 Weeks
Percent change from baseline in high density lipoprotein-cholesterol
Timeframe: 12 Weeks
Mean percent change from baseline in very low-density lipoprotein cholesterol
Timeframe: 10 and 12 Weeks
Percent change from baseline in very low-density lipoprotein cholesterol
Timeframe: 12 Weeks