Clinical trial
LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
Name
20101155
Description
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.
Trial arms
Trial start
2011-07-01
Estimated PCD
2012-04-05
Trial end
2012-04-05
Status
Completed
Phase
Early phase I
Treatment
Evolocumab
Administered by subcutaneous injection
Arms:
Evolocumab 105 mg Q2W, Evolocumab 140 mg Q2W, Evolocumab 280 mg Q4W, Evolocumab 350 mg Q4W, Evolocumab 420 mg Q4W, Evolocumab 70 mg Q2W
Other names:
AMG 145, Repatha
Placebo to Evolocumab
Administered by subcutaneous injection
Arms:
Placebo Q2W, Placebo Q4W
Size
631
Primary endpoint
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline and Week 12
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 631, 'type': 'ACTUAL'}}
Updated at
2022-11-15
1 organization
1 product
1 indication
Product
EvolocumabIndication
HyperlipidemiaOrganization
Amgen