At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 631 enrolled
Drug / intervention
Evolocumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Evolocumab and Placebo to Evolocumab for Hyperlipidemia. Completed, enrolled 631 participants across 100 sites in 5 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesCanada, Czechia, Denmark, Hungary, United States
CollaboratorsThe TIMI Study Group
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedJun 27, 2011
Enrollment StartJul 1, 2011
Primary CompletionApr 5, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Placebo to Evolocumabother
Administered by subcutaneous injection