Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
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|ClinicalTrials.gov Identifier: NCT02304484|
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Biological: Evolocumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||770 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab|
|Actual Study Start Date :||November 24, 2014|
|Actual Primary Completion Date :||March 9, 2018|
|Actual Study Completion Date :||March 9, 2018|
Participants received 420 mg evolocumab once a month for up to 2 years.
Administered by subcutaneous injection once a month
- Number of Participants With Adverse Events [ Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. ]
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.
An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128 ]
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): NCT02304484