Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

December 10, 2013

Primary Completion Date

November 10, 2015

Study Completion Date

November 21, 2017

Conditions
Hyperlipidemia
Interventions
DRUG

Atorvastatin

Atorvastatin was supplied as over-encapsulated 20 mg tablets

DRUG

Placebo to Atorvastatin

Placebo matching to atorvastatin supplied as over-encapsulated tablets

OTHER

Placebo to Ezetimibe

Placebo matching to Ezetimibe supplied as over-encapsulated tablets.

DRUG

Ezetimibe

Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.

OTHER

Placebo to Evolocumab

Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)

DRUG

Evolocumab

Evolocumab supplied as single-use prefilled autoinjector/pen(s)

Trial Locations (58)

1685

Research Site, Midrand

2015

Research Site, Camperdown

2157

Research Site, Johannesburg

2600

Research Site, Glostrup Municipality

4102

Research Site, Woolloongabba

5035

Research Site, Ashford

6003

Research Site, Ålesund

7505

Research Site, Parow

7925

Research Site, Observatory

8011

Research Site, Christchurch

8200

Research Site, Aarhus N

10029

Research Site, New York

13353

Research Site, Berlin

17405

Research Site, York

20092

Research Site, Cinisello Balsamo (MI)

21201

Research Site, Baltimore

21204

Research Site, Towson

27710

Research Site, Durham

29425

Research Site, Charleston

30322

Research Site, Atlanta

40138

Research Site, Bologna

44093

Research Site, Nantes

44100

Research Site, Ferrara

44195

Research Site, Cleveland

48106

Research Site, Ann Arbor

50937

Research Site, Cologne

55905

Research Site, Rochester

56124

Research Site, Pisa

61081

Research Site, Sterling

63110

Research Site, St Louis

66160

Research Site, Kansas City

69200

Research Site, Vénissieux

75651

Research Site, Paris

77030

Research Site, Houston

80638

Research Site, München

90048

Research Site, Los Angeles

90211

Research Site, Beverly Hills

90732

Research Site, San Pedro

92648

Research Site, Huntington Beach

V5Z 1M9

Research Site, Vancouver

L8L 2X2

Research Site, Hamilton

N6A 4V2

Research Site, London

K9J 0B2

Research Site, Peterborough

H2W 1R7

Research Site, Montreal

G1V 4M6

Research Site, Québec

J6E 6J2

Research Site, Saint-Charles-Borromée

500 05

Research Site, Hradec Králové

128 08

Research Site, Prague

140 21

Research Site, Prague

09134

Research Site, Cagliari

06129

Research Site, Perugia

1105 AZ

Research Site, Amsterdam

3045 PM

Research Site, Rotterdam

3331 LZ

Research Site, Zwijndrecht

0373

Research Site, Oslo

B15 2TH

Research Site, Birmingham

G12 8TA

Research Site, Glasgow

NE1 4LP

Research Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY