A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Phase: PHASE3
Conditions: Hypercholesterolemia
Sponsor: Amgen

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Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 1 of 9 
CONFIDENTIAL 
 
 
Amendment 1 
Protocol Title:  A Multicenter, Open-label Extension (OLE) Study to Assess the 
Long-term Safety and Efficacy of Evolocumab 
 
Amgen Protocol Number 20140128 
 
Amendment Date: 
22 December 2014 
 
Rationale: 
This document provides the rationale and detailed list of changes for Protocol 
Amendment 1, dated 22 December 2014, from the original study protocol, dated 
23 June 2014.  
The purpose of the amendment is to: 
 
Update Key Sponsor Contact information 
 
Minor updates and clarifications 
 

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Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 3 of 9 
CONFIDENTIAL
Replace: 
I have read the attached protocol entitled “A Multicenter, Open-label Extension (OLE) 
Study to Assess the Long-term Safety and Efficacy of Evolocumab”, dated 23 June 
2014, and agree to abide by all provisions set forth therein. 
With: 
I have read the attached protocol entitled “A Multicenter, Open-label Extension (OLE) 
Study to Assess the Long-term Safety and Efficacy of Evolocumab”, dated 22 
December 2014, and agree to abide by all provisions set forth therein. 
Section:  Protocol Synopsis, “Study Design” 
Replace:  
Subjects who completed study 20120153 and completed IP in 20120153 will be eligible 
to enroll in this study. 
With: 
Subjects who completed study 20120153 and completed Investigational Product (IP) 
in 20120153 will be eligible to enroll in this study. 
Section:  Protocol Synopsis, “Procedures” 
2nd paragraph 
Replace: 
Subjects will visit the site on Day 1 and week 4. Thereafter, subjects will visit the site 
quarterly for the first year and two additional times during year 2. During these visits vital 
signs will be obtained and adverse events (AEs), serious adverse events (SAEs), 
concomitant medications will be recorded, and central laboratory tests will be performed 
for all subjects. 
With: 
Subjects will visit the site on Day 1 and week 4. Thereafter, subjects will visit the site 
quarterly for the first year and two additional times during year 2. During these visits vital 
signs will be obtained and adverse events (AEs), serious adverse events (SAEs), 
concomitant medications will be recorded, and central laboratory tests will be performed 
for all subjects.  In addition to the protocol-specified study procedures and 
assessments, investigators should continue to routinely monitor subjects 

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 4 of 9 
CONFIDENTIAL 
 
 
according to local disease management guidelines and perform assessments (eg, 
ECG, hemoglobin A1c, eGFR, and hematology), as applicable, in routine care. 
Section:  Study Design and Treatment Schema 
Replace:  
 
With: 
 

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 5 of 9 
CONFIDENTIAL 
 
 
Section:  Study Glossary 
Add:  
eGFR 
estimated Glomerular Filtration Rate 
HbA1c 
Hemoglobin A1c 
Section: 4.2, Exclusion Criteria 
2nd paragraph 
Replace:  
1. Female subject of reproductive potential not willing to inform her sexual partner 
of her participation in the clinical study and to use an acceptable method(s) of 
birth control during treatment with evolocumab and for an additional 15 weeks 
after the end of treatment with evolocumab.  Female subjects who have had a 
hysterectomy, bilateral salpingectomy, bilateral oophorectomy,bilateral tubal 
ligatio or who are postmenopausal are not required to use contraception.  
o Postmenopausal is defined as: Age > 55 years with cessation of menses 
for 12 months or more; Age < 55 by no spontaneous menses for at least 
2 years; Age < 55 years and no spontaneous menses within the past 
1 year, but currently amenorrheic AND with postmenopausal 
gonadrotropin levels (luteinizing hormone and follicle-stimulating hormone 
levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or 
according to the definition of “postmenopausal range” for the laboratory 
involved. 
o Acceptable methods of birth control include: sexual  abstinence,  surgical 
contraceptive methods (vasectomy or bilateral tubal ligation), use of 
hormonal birth control methods (pills, shots, implants or patches), 
intrauterine devices (IUDs), or two (2) barrier methods (each partner must 
use one barrier method) with spermicide – males must use a condom with 
spermicide; females must choose either a Diaphragm with spermicide, 
OR Cervical cap with spermicide, OR Contraceptive sponge with 
spermicide.  

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 6 of 9 
CONFIDENTIAL 
 
 
 
Note:  Additional medications given during treatment with 
evolocumab may alter the contraceptive requirements. These 
additional medications may require an increase in the number of 
contraceptive methods and/or length of time that contraception is 
to be utilized after the last dose of protocol-required therapies. 
The investigator is to discuss these contraceptive changes with 
the study subject. 
With: 
1. Female subject of reproductive potential not willing to inform her sexual partner 
of her participation in the clinical study and to use an acceptable method(s) of 
effective birth control during treatment with evolocumab and for an additional 
15 weeks after the end of treatment with evolocumab.  Female subjects who 
have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or 
who are postmenopausal are not required to use contraception.  
o Postmenopausal is defined as: Age > 55 years with cessation of menses 
for 12 months or more; Age < 55 by no spontaneous menses for at least 
2 years; Age < 55 years and no spontaneous menses within the past 
1 year, but currently amenorrheic AND with postmenopausal 
gonadotropin levels (luteinizing hormone and follicle-stimulating hormone 
levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or 
according to the definition of “postmenopausal range” for the laboratory 
involved. 
o Acceptable methods of effective birth control include: sexual 
abstinence (when this is in line with the preferred and usual lifestyle 
of the subject. [Periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), declaration of abstinence 
for the duration of a trial, and withdrawal are not acceptable 
methods of contraception]),  surgical contraceptive methods 
(vasectomy or bilateral tubal ligation), use of hormonal birth control 
methods (pills, shots, implants or patches), intrauterine devices (IUDs), or 
two (2) barrier methods (each partner must use one barrier method) with 
spermicide – males must use a condom with spermicide; females must 
choose either a Diaphragm with spermicide, OR Cervical cap with 
spermicide, OR Contraceptive sponge with spermicide.  

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 7 of 9 
CONFIDENTIAL 
 
 
 
 
Note:  Additional medications given during treatment with 
evolocumab may alter the contraceptive requirements. These 
additional medications may require an increase in the number of 
contraceptive methods and/or length of time that contraception is 
to be utilized after the last dose of protocol-required therapies. 
The investigator is to discuss these contraceptive changes with 
the study subject. 
Section:  7, Study Procedures 
Add:  
In addition to the protocol-specified study procedures and assessments 
described below, investigators should continue to routinely monitor subjects 
according to local disease management guidelines and perform assessments 
(eg ECG, hemoglobin A1c, eGFR, and hematology), as applicable, in routine care. 
Section:  8.1, Removal of Subjects 
Replace:  
Reasons for removal from protocol-required investigational product might include: 
With:  
Reasons for removal from protocol-required investigational product include, but are not 
limited to: 

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 8 of 9 
CONFIDENTIAL 
 
 
Section:  Appendix B, Sample Serious Adverse Event Report Form 
Replace:  
 

Product:  Evolocumab 
Protocol Number:  20140128 
Date:  22 December 2014 
Page 9 of 9 
CONFIDENTIAL 
 
 
With: