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Study Complete
Sponsor ID
20120138

Open-label Extension Study of Evolocumab (AMG 145) in Adults with Hyperlipidemia and Mixed DyslipidemiaOSLER-2

Sponsor ID
20120138
Clinicaltrials.gov ID
NCT01854918
EUCTIS ID
N/A
EudraCT ID
2012-004357-83
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Study Details

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
3681
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of adverse events

Timeframe: 156 weeks

Secondary Outcome Measures

Percent change from baseline in LDL-C at weeks 48 and 104

Timeframe: Weeks 48 & 104

Change from baseline in LDL-C at weeks 48 and 104

Timeframe: Weeks 48 & 104

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Aalborg, Denmark, 9000
Status
Recruiting
Location
Research Site
Akron, OH, United States, 44311
Status
Recruiting
Location
Research Site
Amsterdam, Netherlands, 1105 AZ
Status
Recruiting
Location
Research Site
Anderson, SC, United States, 29621
Status
Recruiting
Location
Research Site
Anthée, Belgium, 5520
Status
Recruiting
Location
Research Site
Ashford, SA, Australia, 5035
Status
Recruiting
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Study Info
Age
18 - 85 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Apr 2013 - May 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).
    Exclusion Criteria:
    - Experienced a treatment-related serious adverse event that led to study drug 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)