A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Overview
- Phase
- Phase 3
- Intervention
- Evolocumab
- Conditions
- Hyperlipidemia and Mixed Dyslipidemia
- Sponsor
- Amgen
- Enrollment
- 3681
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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)
Arms & Interventions
Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.
Intervention: Evolocumab
Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period.
Intervention: Standard of Care
Evolocumab + Standard of Care
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
Intervention: Evolocumab
Evolocumab + Standard of Care
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
Intervention: Standard of Care
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Secondary Outcomes
- Percent Change From Baseline in LDL-C at Weeks 48 and 104(Baseline of the parent study and weeks 48 amd 104)
- Change From Baseline in LDL-C at Weeks 48 and 104(Baseline of the parent study and weeks 48 amd 104)