LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/4/2018 |
| Start Date: | July 1, 2011 |
| End Date: | April 5, 2012 |
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
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.
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.
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
We found this trial at
52
sites
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