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

Conditions

• Hyperlipidemia and Mixed Dyslipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — BIOLOGICAL
  Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
• Standard of Care — DRUG
  Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Study Details

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.

Key Dates

Start date

Apr 23, 2013

Status verified

May 2019

Primary completion

May 31, 2018

Completion

May 31, 2018

Study Design

Enrollment

3,681 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

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 ]

Locations (107)

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