Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments evolocumab (amg 145) and standard of care, standard of care
Phase phase 2
Sponsor Amgen
Start date October 2011
End date June 2018
Trial size 1324 participants
Trial identifier NCT01439880, 20110110

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ASSIGNED TO [1] INTERVENTION(S)
evolocumab (amg 145) and standard of care
Evolocumab (AMG 145) is a fully human monoclonal antibody against PCSK9. Standard of care therapy is per local practice; this could include prescribed therapies and/or dietary/exercise regimes
(Active Comparator)
Standard of care therapy as per local practice
standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Primary Outcomes

Measure
Subject incidence of treatment emergent adverse events
time frame: Approximately 1 year

Secondary Outcomes

Measure
Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52
time frame: Approximately 1 year
Absolute non-high density lipoprotein cholesterol (non-HDL-C) at week 24 and week 52
time frame: Approximately 1 year
Absolute apolipoprotein B (ApoB) at week 24 and week 52
time frame: Approximately 1 year
Absolute total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio at week 24 and week 52
time frame: Approximately 1 year
Absolute Apolipoprotein B (ApoeB)/Apolipoprotein A1 (ApoA1) ratio at week 24 and week 52
time frame: Approximately 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Complete a qualifying evolocumab (AMG 145) parent study protocol Exclusion Criteria: - Experienced a treatment-related serious adverse event that led to 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)

Additional Information

Official title A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Amgen.