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Study Complete
Sponsor ID
20110115

LDL-C assessment with PCSK9 monoclonal antibody inhibition combined with statin therapy-2LAPLACE-2

Sponsor ID
20110115
Clinicaltrials.gov ID
NCT01763866
EUCTIS ID
N/A
EudraCT ID
2012-001363-70
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Study Details

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
2067
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 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 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
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Florence, SC, United States, 29501
Status
Completed
Location
Research Site
San Diego, CA, United States, 92123
Status
Completed
Location
Research Site
Cadiz, OH, United States, 43907
Status
Recruiting
Location
Research Site
Moscow, Russian Federation, 121002
Status
Recruiting
Location
Research Site
Aalborg, Denmark, 9000
Status
Recruiting
Location
Research Site
Almería, Andalucía, Spain, 04001
Status
Recruiting
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Study Info
Age
18 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Jan 2013 - Nov 2013
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Male or female ≥ 18 to ≤ 80 years of age - Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L) - Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L) - Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L) - Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
    Exclusion Criteria:
    - Statin intolerance - New York Heart association (NYHA) III or IV heart failure - Uncontrolled hypertension - Uncontrolled cardiac arrhythmia - Type 1 diabetes, poorly controlled type 2 diabetes - Uncontrolled hypothyroidism or hyperthyroidism