Study Complete
Sponsor ID
20120348

Study to assess in-home use of evolocumab (AMG 145) using a prefilled syringe or a prefilled autoinjector/pen

Sponsor ID
20120348
Clinicaltrials.gov ID
NCT01849497
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study was to assess users’ ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
149
Additional Study Details

Protocol Summary

Primary Outcome Measures

Combination of subject reported outcomes across two attempted full-dose administrations of evolocumab (AMG 145)

Timeframe: 4 weeks

Secondary Outcome Measures

Percent change from baseline in LDL-C at week 6

Timeframe: 6 Weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Lansdale, PA, United States, 19446
Status
Recruiting
Location
Research Site
Manlius, NY, United States, 13104
Status
Recruiting
Location
Research Site
Miami, FL, United States, 33173
Status
Recruiting
Location
Research Site
Pointe-Claire, QC, Canada, H9R 3J1
Status
Recruiting
Location
Research Site
Port Charlotte, FL, United States, 33952
Status
Recruiting
Location
Research Site
Atlanta, GA, United States, 30342
Status
Recruiting
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