Study Complete
Sponsor ID
20110116

Goal achievement after utilizing an anti-PCSK9 antibody in statin intolerant subjects -2GAUSS-2

Sponsor ID
20110116
Clinicaltrials.gov ID
NCT01763905
EUCTIS ID
N/A
EudraCT ID
2012-001364-30

Study Details

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), 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 (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
307
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Aalborg, Denmark, 9000
Status
Completed
Location
Research Site
Akron, OH, United States, 44311
Status
Completed
Location
Research Site
Atlanta, GA, United States, 30338
Status
Completed
Location
Research Site
Atlanta, GA, United States, 30342
Status
Completed
Location
Research Site
Auburn, ME, United States, 04210
Status
Completed
Location
Research Site
Bad Krozingen, Germany, 79189
Status
Completed
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