Trial Outcomes & Findings for Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen (NCT NCT01879319)
NCT ID: NCT01879319
Last Updated: 2022-11-30
Results Overview
Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
Weeks 4 and 8
Results posted on
2022-11-30
Participant Flow
Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks. The first patient enrolled on 11 July 2013 and the last patient enrolled on 20 September 2013.
Randomization was stratified on the basis of screening LDL-C concentration (\< 130 mg/dL \[3.4 mmol/L\] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.
Participant milestones
| Measure |
Evolocumab AMD
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
|
Evolocumab AI/Pen
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
Received Treatment
|
82
|
82
|
|
Overall Study
COMPLETED
|
80
|
77
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Evolocumab AMD
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
|
Evolocumab AI/Pen
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
Baseline characteristics by cohort
| Measure |
Evolocumab AMD
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
|
Evolocumab AI/Pen
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
69 participants
n=5 Participants
|
75 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
78 participants
n=5 Participants
|
76 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Stratification Factor: LDL-C Level
< 130 mg/dL
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Stratification Factor: LDL-C Level
≥ 130 mg/dL
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
LDL-C Concentration
|
115.3 mg/dL
STANDARD_DEVIATION 27.0 • n=5 Participants
|
117.3 mg/dL
STANDARD_DEVIATION 23.9 • n=7 Participants
|
116.3 mg/dL
STANDARD_DEVIATION 25.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 4 and 8Population: Full analysis set
Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.
Outcome measures
| Measure |
Evolocumab AMD
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
|
Evolocumab AI/Pen
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
|
|---|---|---|
|
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8
|
93.9 Percentage of participants
Interval 86.5 to 97.4
|
91.5 Percentage of participants
Interval 83.4 to 95.8
|
SECONDARY outcome
Timeframe: Baseline and Weeks 10 and 12Population: Full analysis set
Outcome measures
| Measure |
Evolocumab AMD
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
|
Evolocumab AI/Pen
n=82 Participants
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
|
-67.9 percent change
Standard Error 2.4
|
-64.5 percent change
Standard Error 2.4
|
Adverse Events
Evolocumab AMD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evolocumab AI/Pen
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evolocumab AMD
n=82 participants at risk
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
|
Evolocumab AI/Pen
n=82 participants at risk
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/82 • From first dose of study drug until 28 days after last study drug administration (up to 12 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/82 • From first dose of study drug until 28 days after last study drug administration (up to 12 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER