Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension (FOURIER OLE)
|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: NCT02867813|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia||Biological: Evolocumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5037 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease|
|Actual Study Start Date :||September 2, 2016|
|Estimated Primary Completion Date :||September 29, 2021|
|Estimated Study Completion Date :||September 29, 2021|
Experimental: evolocumab (AMG 145)
All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
- Subject incidence of adverse events [ Time Frame: 5 years ]
- Percent change of LDL-C from baseline at each scheduled visit [ Time Frame: 5 years ]
- Achieve an LDL-C < 40 mg/dL (1.03 mmol/L) at each scheduled visit [ Time Frame: 5 years ]
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): NCT02867813