GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Amgen
Study ID
NCT01813422
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
  • Placebo — DRUG
    Administered by subcutaneous injection

Study Details

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

Key Dates

Start date
Apr 18, 2013
Status verified
Feb 2019
Primary completion
Jul 12, 2016
Completion
Jul 29, 2016

Study Design

Enrollment
970 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
  • Experimental: Evolocumab
    Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Primary Outcome Measure

Change From Baseline in Percent Atheroma Volume at Week 78 [ Time Frame: Baseline and week 78 ]

Locations (59)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteLittle RockArkansas72211-
Research SiteLa JollaCalifornia92037-
Research SiteLa JollaCalifornia92093-0960-
Research SiteLong BeachCalifornia90822-
Research SiteNewport BeachCalifornia92663-
Research SiteOrangeCalifornia92868-
Research SiteSan DiegoCalifornia92161-
Research SiteSanta MonicaCalifornia90404-
Research SiteTorranceCalifornia90502-
Research SiteWashington D.C.District of Columbia20010-
Research SiteAtlantisFlorida33462-
Research SiteClearwaterFlorida33756-
Research SiteJacksonvilleFlorida32209-
Research SiteJacksonvilleFlorida32216-
Research SiteMelbourneFlorida32901-
Research SiteSafety HarborFlorida34695-
Research SiteAtlantaGeorgia30342-
Research SiteHammondIndiana46320-
Research SiteValparaisoIndiana46383-
Research SiteLexingtonKentucky40536-
Research SiteLouisvilleKentucky40205-
Research SiteCovingtonLouisiana70433-
Research SiteBethesdaMaryland20814-
Research SiteColumbiaMaryland21044-
Research SiteAnn ArborMichigan48109-
Research SiteBay CityMichigan48708-
Research SiteGrand RapidsMichigan49503-
Research SiteMarquetteMichigan49855-
Research SiteMidlandMichigan48670-
Research SitePetoskeyMichigan49770-
Research SiteSaginawMichigan48601-
Research SiteDuluthMinnesota55805-
Research SiteMinneapolisMinnesota55407-
Research SiteSaint CloudMinnesota56303-
Research SiteSaint PaulMinnesota55102-
Research SiteColumbiaMissouri65212-
Research SiteMissoulaMontana59802-
Research SiteOmahaNebraska68198-
Research SiteRidgewoodNew Jersey07450-
Research SiteBuffaloNew York14215-
Research SiteJohnson CityNew York13790-
Research SiteCharlotteNorth Carolina28204-
Research SiteFargoNorth Dakota58122-
Research SiteCantonOhio44710-
Research SiteElyriaOhio44035-
Research SiteToledoOhio43614-
Research SiteOklahoma CityOklahoma73104-
Research SiteTulsaOklahoma74104-
Research SiteHillsboroOregon97123-
Research SiteSpringfieldOregon97477-
Research SiteDoylestownPennsylvania18901-
Research SiteHersheyPennsylvania17033-
Research SiteOak RidgeTennessee37830-
Research SiteAmarilloTexas79106-
Research SiteDallasTexas75216-
Research SiteSan AntonioTexas78229-
Research SiteWichita FallsTexas76301-

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