Study Complete
Sponsor ID
20120122

Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular RiskAMG145

Sponsor ID
20120122
Clinicaltrials.gov ID
NCT01953328
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
409
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

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 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 total cholesterol

Timeframe: 10 and 12 Weeks

Percent change from baseline in total cholesterol

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 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 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
Akita-shi, Akita, Japan, 010-1423
Status
Recruiting
Location
Research Site
Arakawa-ku, Tokyo, Japan, 116-0002
Status
Recruiting
Location
Research Site
Chiyoda-ku, Tokyo, Japan, 101-0041
Status
Recruiting
Location
Research Site
Chuo-ku, Tokyo, Japan, 103-0027
Status
Recruiting
Location
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-0014
Status
Recruiting
Location
Research Site
Fukuoka-shi, Fukuoka, Japan, 810-0066
Status
Recruiting
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