Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03080935|
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia||Drug: Evolocumab||Phase 3|
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). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.
The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.
Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.
This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.
All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries|
|Actual Study Start Date :||March 13, 2017|
|Estimated Primary Completion Date :||December 4, 2022|
|Estimated Study Completion Date :||December 4, 2022|
Single arm study administering Evolocumab.
Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Other Name: AMG 145
- Adverse event measurement [ Time Frame: 5 years ]
- The primary endpoint is the subject incidence of adverse events.
- Subject safety will be measured by tracking adverse events.
- Percent change of LDL-C [ Time Frame: 5 years ]The secondary end point is the percent change of LDL-C from baseline at each scheduled visit.
- Achievement of an LDL-C < 40 mg/dL [ Time Frame: 5 years ]The achievement of an LDL-C < 40 mg/dL (1.03 mmol/L) at each scheduled visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080935