Hyperlipidemia Clinical Trial
— LAPLACEOfficial title:
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
| NCT number | NCT01380730 |
| Other study ID # | 20101155 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 1, 2011 |
| Est. completion date | April 5, 2012 |
| Verified date | November 2022 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 631 |
| Est. completion date | April 5, 2012 |
| Est. primary completion date | April 5, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Burnaby | British Columbia |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Gatineau | Quebec |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Kelowna | British Columbia |
| Canada | Research Site | Lachine | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Longueuil | Quebec |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Pointe-Claire | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sarnia | Ontario |
| Canada | Research Site | Scarborough | Ontario |
| Canada | Research Site | Sudbury | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Woodstock | Ontario |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 4 | |
| Czechia | Research Site | Slany | |
| Czechia | Research Site | Svitavy | |
| Czechia | Research Site | Usti nad Orlici | |
| Czechia | Research Site | Znojmo | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Ballerup | |
| Denmark | Research Site | Vejle | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Dunaujvaros | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Kecskemet | |
| Hungary | Research Site | Komarom | |
| Hungary | Research Site | Mosonmagyarovar | |
| Hungary | Research Site | Szolnok | |
| Hungary | Research Site | Zalaegerszeg | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Camp Hill | Pennsylvania |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Carmichael | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Cortlandt Manor | New York |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Daytona Beach | Florida |
| United States | Research Site | Florence | South Carolina |
| United States | Research Site | Great Falls | Montana |
| United States | Research Site | Green Cove Springs | Florida |
| United States | Research Site | Hammond | Indiana |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Littleton | Colorado |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Malvern | Arkansas |
| United States | Research Site | Mansfield | Ohio |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Marquette | Michigan |
| United States | Research Site | Melbourne | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Peoria | Illinois |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Portland | Maine |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Roseville | California |
| United States | Research Site | Sandusky | Ohio |
| United States | Research Site | Smithfield | North Carolina |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Voorhees | New Jersey |
| United States | Research Site | Westlake Village | California |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | York | Pennsylvania |
| United States | Research Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen | TIMI Study Group |
United States, Canada, Czechia, Denmark, Hungary,
Giugliano RP, Desai NR, Kohli P, Rogers WJ, Somaratne R, Huang F, Liu T, Mohanavelu S, Hoffman EB, McDonald ST, Abrahamsen TE, Wasserman SM, Scott R, Sabatine MS; LAPLACE-TIMI 57 Investigators. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study. Lancet. 2012 Dec 8;380(9858):2007-17. doi: 10.1016/S0140-6736(12)61770-X. Epub 2012 Nov 6. — View Citation
Kohli P, Desai NR, Giugliano RP, Kim JB, Somaratne R, Huang F, Knusel B, McDonald S, Abrahamsen T, Wasserman SM, Scott R, Sabatine MS. Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35(7):385-91. doi: 10.1002/clc.22014. Epub 2012 Jun 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | LDL-C was measured using ultracentrifugation. | Baseline and Week 12 | |
| Secondary | Change From Baseline in LDL-C at Week 12 | LDL-C was measured using ultracentrifugation. | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | Baseline and Week 12 |
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