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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,681
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
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.
Time frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Percent Change From Baseline in LDL-C at Weeks 48 and 104
Time frame: Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104
Time frame: Baseline of the parent study and weeks 48 amd 104
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Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Beverly Hills, California, United States
Research Site
Carmichael, California, United States
Research Site
Encinitas, California, United States
Research Site
Huntington Beach, California, United States
...and 353 more locations