Trial · NCT01849497
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
NCT01849497, Phase 3, Completed, Amgen; results first posted 2015-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen. Trials, record NCT01849497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01849497
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
- NCT number
- NCT01849497
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- First posted
- 2013-05-08
- Last updated
- 2018-11-29
- Results first posted
- 2015-10-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Week 2 and Week 4 | 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. |
| Secondary | Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Week 2 and Week 4 | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Evolocumab PFS | 96.0 | 95% Confidence Interval 88.9 to 98.6 | percentage of participants | |
| Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Evolocumab AI/Pen | 89.2 | 95% Confidence Interval 80.1 to 94.4 | percentage of participants | |
| Percent Change From Baseline in LDL-C at Week 6 | Evolocumab PFS | -59.74 | Standard Error 2.57 | percent change | |
| Percent Change From Baseline in LDL-C at Week 6 | Evolocumab AI/Pen | -63.43 | Standard Error 2.67 | percent change |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Evolocumab PFS | 75 | |
| Overall Study | STARTED | Evolocumab AI/Pen | 74 | |
| Overall Study | Received Treatment | Evolocumab PFS | 75 | |
| Overall Study | Received Treatment | Evolocumab AI/Pen | 74 | |
| Overall Study | COMPLETED | Evolocumab PFS | 74 | |
| Overall Study | COMPLETED | Evolocumab AI/Pen | 70 | |
| Overall Study | NOT COMPLETED | Evolocumab PFS | 1 | |
| Overall Study | NOT COMPLETED | Evolocumab AI/Pen | 4 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Evolocumab PFS | 4 | 75 | |
| other | Headache | Nervous system disorders | Evolocumab AI/Pen | 2 | 74 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Evolocumab PFS | 1 | 75 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Evolocumab AI/Pen | 0 | 74 | |
| serious | Cholecystitis | Hepatobiliary disorders | Evolocumab PFS | 1 | 75 | |
| serious | Cholecystitis | Hepatobiliary disorders | Evolocumab AI/Pen | 0 | 74 | |
| serious | Cholelithiasis | Hepatobiliary disorders | Evolocumab PFS | 1 | 75 | |
| serious | Cholelithiasis | Hepatobiliary disorders | Evolocumab AI/Pen | 0 | 74 | |
| serious | Cerebrovascular accident | Nervous system disorders | Evolocumab PFS | 0 | 75 | |
| serious | Cerebrovascular accident | Nervous system disorders | Evolocumab AI/Pen | 1 | 74 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Evolocumab PFS | ||
| Total, all-cause mortality | Evolocumab AI/Pen | ||
| Total, other adverse events | Evolocumab PFS | 4 | 75 |
| Total, other adverse events | Evolocumab AI/Pen | 2 | 74 |
| Total, serious adverse events | Evolocumab PFS | 3 | 75 |
| Total, serious adverse events | Evolocumab AI/Pen | 2 | 74 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Evolocumab PFS vs Evolocumab AI/Pen: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01849497
GET https://conductscience.org/api/trials/v1/NCT01849497/registered