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Study Complete
Sponsor ID
20101155

LAPLACE-TIMI 57: Low-density lipoprotein cholesterol (LDL-C) Assessment with PCSK9 monoclonaL Antibody inhibition Combined with statin thErapyLAPLACE

Sponsor ID
20101155
Clinicaltrials.gov ID
NCT01380730
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Additional Study Details

Phase
Phase 2
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
631
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary endpoint is the percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12

Timeframe: 12 weeks

Secondary Outcome Measures

Absolute change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12

Timeframe: 12 weeks

Percent change from baseline in non-High Density Lipoprotein Cholesterol (HDL-C) at week 12

Timeframe: 12 weeks

Percent change from baseline in Apolipoprotein B (ApoB) at week 12

Timeframe: 12 weeks

Percent change from baseline in the total cholesterol/High Density Lipoprotein Cholesterol (HDL-C) ratio at week 12

Timeframe: 12 weeks

Percent change from baseline in Apolipoprotein B (ApoB)/Apolipoprotein A-1 (ApoA1) ratio at week 12

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Oshawa, ON, Canada, L1J 2J9
Status
Completed
Location
Research Site
Oshawa, ON, Canada, L1J 2K1
Status
Completed
Location
Research Site
Longueuil, QC, Canada, J4N 0C9
Status
Completed
Location
Research Site
Hamilton, ON, Canada, L8L 2X2
Status
Completed
Location
Research Site
Cambridge, ON, Canada, N1R 6V6
Status
Recruiting
Location
Research Site
Sudbury, ON, Canada, P3C 5K7
Status
Completed
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Study Info
Age
18 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Jul 2011 - Apr 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Male or female ≥ 18 to ≤ 80 years of age - On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks - Fasting LDL-C ≥ 85 mg/dL - Fasting triglycerides ≤ 400 mg/dL
    Exclusion Criteria:
    - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization - Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%) - Uncontrolled hypertension - New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30% - Uncontrolled cardiac arrhythmia