Trial Outcomes & Findings for Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen (NCT NCT01849497)
NCT ID: NCT01849497
Last Updated: 2018-11-29
Results Overview
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
Week 2 and Week 4
Results posted on
2018-11-29
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 18 April 2013 and last patient enrolled on 05 August 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 PFS
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
|
Evolocumab AI/Pen
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
Received Treatment
|
75
|
74
|
|
Overall Study
COMPLETED
|
74
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Evolocumab PFS
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
|
Evolocumab AI/Pen
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Baseline characteristics by cohort
| Measure |
Evolocumab PFS
n=75 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
|
Evolocumab AI/Pen
n=74 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
60.6 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
7 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 participants
n=93 Participants
|
7 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=93 Participants
|
58 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
66 participants
n=93 Participants
|
68 participants
n=4 Participants
|
134 participants
n=27 Participants
|
|
Stratification Factor: LDL-C Level
< 130 mg/dL
|
56 participants
n=93 Participants
|
56 participants
n=4 Participants
|
112 participants
n=27 Participants
|
|
Stratification Factor: LDL-C Level
≥ 130 mg/dL
|
19 participants
n=93 Participants
|
18 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
LDL-C Concentration
|
116.9 mg/dL
STANDARD_DEVIATION 25.0 • n=93 Participants
|
118.1 mg/dL
STANDARD_DEVIATION 28.7 • n=4 Participants
|
117.5 mg/dL
STANDARD_DEVIATION 26.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 2 and Week 4Population: Full analysis set
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
Outcome measures
| Measure |
Evolocumab PFS
n=75 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
|
Evolocumab AI/Pen
n=74 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
|
|---|---|---|
|
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4
|
96.0 percentage of participants
Interval 88.9 to 98.6
|
89.2 percentage of participants
Interval 80.1 to 94.4
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Full analysis set
Outcome measures
| Measure |
Evolocumab PFS
n=75 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
|
Evolocumab AI/Pen
n=74 Participants
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 6
|
-59.74 percent change
Standard Error 2.57
|
-63.43 percent change
Standard Error 2.67
|
Adverse Events
Evolocumab PFS
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Evolocumab AI/Pen
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evolocumab PFS
n=75 participants at risk
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
|
Evolocumab AI/Pen
n=74 participants at risk
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.3%
1/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Glomerulonephritis minimal lesion
|
0.00%
0/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
1/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
1/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Evolocumab PFS
n=75 participants at risk
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
|
Evolocumab AI/Pen
n=74 participants at risk
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.3%
4/75 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
2/74 • From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
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