At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 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.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin
In Brief
A Phase 1 clinical trial evaluating Evolocumab and Placebo for Hyperlipidemia. Completed, enrolled 60 participants.
Detailed Summary
The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionSep 2011
TodayJul 2026
First PostedMay 31, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 14, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Placebobiological
Administered by subcutaneous injection