Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Amgen
Study ID
NCT02304484
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection once a month

Study Details

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Key Dates

Start date
Nov 24, 2014
Status verified
Feb 2019
Primary completion
Mar 9, 2018
Completion
Mar 9, 2018

Study Design

Enrollment
770 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Participants received 420 mg evolocumab once a month for up to 2 years.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. ]

Locations (24)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteLong BeachCalifornia90822-
Research SiteSan DiegoCalifornia92161-
Research SiteTorranceCalifornia90502-
Research SiteJacksonvilleFlorida32216-
Research SiteMunsterIndiana46321-
Research SiteLexingtonKentucky40536-
Research SiteCovingtonLouisiana70433-
Research SiteBethesdaMaryland20814-
Research SiteColumbiaMaryland21044-
Research SiteBay CityMichigan48708-
Research SiteMidlandMichigan48670-
Research SiteDuluthMinnesota55805-
Research SiteSaint CloudMinnesota56303-
Research SiteColumbiaMissouri65212-
Research SiteRidgewoodNew Jersey07450-
Research SiteFargoNorth Dakota58122-
Research SiteCantonOhio44710-
Research SiteToledoOhio43614-
Research SiteOak RidgeTennessee37830-
Research SiteAmarilloTexas79106-
Research SiteDallasTexas75216-
Research SiteWichita FallsTexas76301-

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