Study Complete
Sponsor ID
20080398

Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults with Hyperlipidemia on Stable Doses of a Statin

Sponsor ID
20080398
Clinicaltrials.gov ID
NCT01133522
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
60
Additional Study Details

Protocol Summary

Primary Outcome Measures

The subject incidence of treatment-emergent adverse events and incidence of binding and neutralizing antibodies to AMG 145 as well as changes in vital signs, clinical laboratory safety tests, and electrocardiograms (ECGs).

Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.

Secondary Outcome Measures

PK (pharmacokinetics) concentrations as well as derived PK parameters of unbound AMG 145

Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.

Ratio to baseline and unadjusted LDL-C and PCSK9 (proprotein convertase subtilisin/kexin type 9)

Timeframe: Including a 35-day screening period, the maximum subject participation is 120 days.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.