Study Complete
Sponsor ID
20140316

Evolocumab compared to LDL-C apheresis in patients receiving LDL-C apheresis prior to study enrollment

Sponsor ID
20140316
Clinicaltrials.gov ID
NCT02585895
EUCTIS ID
N/A
EudraCT ID
2015-001343-37

Study Details

To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
39
Additional Study Details

Protocol Summary

Primary Outcome Measures

Apheresis avoidance at the end of randomized therapy, defined as no apheresis at week 5 and week 6

Timeframe: Week 5

Apheresis avoidance at the end of randomized therapy, defined as no apheresis at week 5 and week 6

Timeframe: Week 6

Secondary Outcome Measures

Percent change from baseline in low density lipoprotein-cholesterol

Timeframe: Week 4

Percent change from baseline in non-high density lipoprotein-cholesterol

Timeframe: Week 4

Percent change from baseline in total cholesterol/high density lipoprotein-cholesterol ratio

Timeframe: Week 4

Locations

Location
Status
Contact Us
Location
Research Site
Boca Raton, FL, United States, 33434
Status
Recruiting
Location
Research Site
Grandville, MI, United States, 49418
Status
Recruiting
Location
Research Site
Bron, France, 69677
Status
Recruiting
Location
Research Site
Dresden, Germany, 01307
Status
Recruiting
Location
Research Site
Nantes Cedex 1, France, 44093
Status
Recruiting
Location
Research Site
Sevilla, Andalucía, Spain, 41013
Status
Recruiting
Showing {first} - {last} of {total} Results