Open Label Study of Long Term Evaluation Against LDL-C Trial

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — BIOLOGICAL
  Administered by subcutaneous injection
• Standard of care — OTHER
  Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Study Details

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Key Dates

Start date

Oct 7, 2011

Status verified

Sep 2022

Primary completion

Jun 20, 2018

Completion

Jun 20, 2018

Study Design

Enrollment

1,324 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 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product \[all-IP\] period.
• Experimental: Evolocumab + SOC
  Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months. ]

Locations (78)

Find similar trials in Birmingham, AL

Related Studies

• Causes and Natural History of Dyslipidemias
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
• Alirocumab in Patients on a Stable Dialysis Regimen
  PHASE3 · Recruiting · Baylor Research Institute · Dallas, Texas
• Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
  PHASE2 · Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
• Pharmacogenomic Informed Statin Prescribing
  Recruiting · VA Office of Research and Development · Indianapolis, Indiana