Overview

This trial is active, not recruiting.

Condition hyperlipidemia and mixed dyslipidemia
Treatments evolocumab (amg 145) and standard of care, standard of care
Phase phase 3
Sponsor Amgen
Start date April 2013
End date August 2018
Trial size 3681 participants
Trial identifier NCT01854918, 20120138

Summary

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed dyslipidemia.

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)
evolocumab (AMG 145) and standard of care
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 adverse events
time frame: 156 weeks

Secondary Outcomes

Measure
Percent change from baseline in LDL-C at weeks 48 and 104
time frame: Weeks 48 & 104
Change from baseline in LDL-C at weeks 48 and 104
time frame: Weeks 48 & 104

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Complete a qualifying evolocumab (AMG 145) parent study 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 145-2
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Amgen.