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

Amgen1,324 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,324

Conditions

Hypercholesterolemia

Interventions

EvolocumabBIOLOGICAL

Administered by subcutaneous injection

Standard of careOTHER

Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703) Exclusion Criteria: * Experienced a treatment-related serious adverse event that led to investigational product (IP) 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)

Locations (187)

Outcomes

Primary Outcomes

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 4.03, 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: 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.