Terminated/Withdrawn
Sponsor ID
20160250

Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Sponsor ID
20160250
Clinicaltrials.gov ID
NCT03080935
EUCTIS ID
N/A
EudraCT ID
2016-004066-26

Study Details

This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
1600
Additional Study Details

Protocol Summary

Primary Outcome Measures

Adverse event measurement

Timeframe: 5 years

Secondary Outcome Measures

Percent change of LDL-C

Timeframe: 5 years

Achievement of an LDL-C < 40 mg/dL

Timeframe: 5 years

Locations

Location
Status
Contact Us
Location
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium, 9300
Status
Recruiting
Location
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerpen, Belgium, 2060
Status
Recruiting
Location
Algemeen Ziekenhuis Sint Lucas
Gent, Belgium, 9000
Status
Recruiting
Location
Medif sprl
Gozee, Belgium, 6534
Status
Recruiting
Location
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
Status
Recruiting
Location
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, Belgium, 2020
Status
Recruiting
Showing {first} - {last} of {total} Results