Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

Conditions
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Hyperlipidemia and Mixed Dyslipidemia

Intervention / Treatment
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* Biological: Evolocumab
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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. | Biological: Evolocumab<br>* Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen<br>* Other names: Repatha;Drug: Standard of Care<br>* Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes<br>|
| Experimental: Evolocumab + Standard of Care<br>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. | Biological: Evolocumab<br>* Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen<br>* Other names: Repatha;Drug: Standard of Care<br>* Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | 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. | 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol