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Study Complete
Sponsor ID
20110110

Open Label Study of Long Term Evaluation Against LDL-C TrialOSLER

Sponsor ID
20110110
Clinicaltrials.gov ID
NCT01439880
EUCTIS ID
N/A
EudraCT ID
2011-001915-29
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Study Details

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Additional Study Details

Phase
Phase 2
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
1324
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment emergent adverse events

Timeframe: Approximately 5 year

Secondary Outcome Measures

Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52

Timeframe: Approximately 1 year

Absolute non-high density lipoprotein cholesterol (non-HDL-C) at week 24 and week 52

Timeframe: Approximately 1 year

Absolute apolipoprotein B (ApoB) at week 24 and week 52

Timeframe: Approximately 1 year

Absolute total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio at week 24 and week 52

Timeframe: Approximately 1 year

Absolute Apolipoprotein B (ApoeB)/Apolipoprotein A1 (ApoA1) ratio at week 24 and week 52

Timeframe: Approximately 1 year

Locations

Location
Status
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Location
Research Site
Ham, Belgium, 3945
Status
Recruiting
Location
Research Site
Halen, Belgium, 3545
Status
Recruiting
Location
Research Site
Gozee, Belgium, 6534
Status
Recruiting
Location
Research Site
Linkebeek, Belgium, 1630
Status
Recruiting
Location
Research Site
Gribomont, Belgium, 6887
Status
Recruiting
Location
Research Site
Toronto, ON, Canada, M9W 4L6
Status
Recruiting
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Study Info
Age
18 - 75 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Oct 2011 - Jun 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
    Exclusion Criteria:
    - Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study - Have an unstable medical condition, in the judgment of the investigator - Known sensitivity to any of the products to be administered during dosing - Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)