Study Complete
Sponsor ID
20120356

Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

Sponsor ID
20120356
Clinicaltrials.gov ID
NCT01879319
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 a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
164
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 8 weeks

Secondary Outcome Measures

Percent change from baseline in LDL-C at weeks 10 and 12

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Marion, OH, United States, 43302
Status
Recruiting
Location
Research Site
Sarnia, ON, Canada, N7T 4X3
Status
Recruiting
Location
Research Site
Cadiz, OH, United States, 43907
Status
Recruiting
Location
Research Site
Ayer, MA, United States, 01432
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75231
Status
Recruiting
Location
Research Site
Lansdale, PA, United States, 19446
Status
Recruiting
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