Trial · NCT01854918
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
NCT01854918, Phase 3, Completed, Amgen; results first posted 2019-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia. Trials, record NCT01854918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01854918
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
- NCT number
- NCT01854918
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,681 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperlipidemia and Mixed Dyslipidemia
- Interventions
- Evolocumab, Standard of Care
- First posted
- 2013-05-16
- Last updated
- 2019-06-11
- Other registries' IDs
- eudract:2012-004357-83
- Results first posted
- 2019-06-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period | Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE. |
| Secondary | Percent Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 | |
| Secondary | Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period | All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-3). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 | Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point. | percent change | MEAN |
| SECONDARY | Change From Baseline in LDL-C at Weeks 48 and 104 | Baseline of the parent study and weeks 48 amd 104 | Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Year 1: Standard of Care | All adverse events | 796 | Participants | |
| Number of Participants With Adverse Events | Year 1: Evolocumab + Standard of Care | All adverse events | 1655 | Participants | |
| Number of Participants With Adverse Events | Years 2-3: SOC / Evolocumab + SOC | All adverse events | 929 | Participants | |
| Number of Participants With Adverse Events | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | All adverse events | 1789 | Participants | |
| Number of Participants With Adverse Events | Year 1: Standard of Care | Adverse events ≥ grade 2 | 519 | Participants | |
| Number of Participants With Adverse Events | Year 1: Evolocumab + Standard of Care | Adverse events ≥ grade 2 | 1070 | Participants | |
| Number of Participants With Adverse Events | Years 2-3: SOC / Evolocumab + SOC | Adverse events ≥ grade 2 | 700 | Participants | |
| Number of Participants With Adverse Events | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | Adverse events ≥ grade 2 | 1339 | Participants | |
| Number of Participants With Adverse Events | Year 1: Standard of Care | Adverse events ≥ grade 3 | 124 | Participants | |
| Number of Participants With Adverse Events | Year 1: Evolocumab + Standard of Care | Adverse events ≥ grade 3 | 225 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| SOC-controlled Period (Year 1) | STARTED | Standard of Care | 1,227 | |
| SOC-controlled Period (Year 1) | STARTED | Evolocumab + Standard of Care | 2,454 | |
| SOC-controlled Period (Year 1) | Received Evolocumab | Standard of Care | 5 | |
| SOC-controlled Period (Year 1) | Received Evolocumab | Evolocumab + Standard of Care | 2,452 | |
| SOC-controlled Period (Year 1) | COMPLETED | Standard of Care | 1,197 | |
| SOC-controlled Period (Year 1) | COMPLETED | Evolocumab + Standard of Care | 2,391 | |
| SOC-controlled Period (Year 1) | NOT COMPLETED | Standard of Care | 30 | |
| SOC-controlled Period (Year 1) | NOT COMPLETED | Evolocumab + Standard of Care | 63 | |
| All-IP Period (Years 2 and 3) | STARTED | Standard of Care | 1,197 | |
| All-IP Period (Years 2 and 3) | STARTED | Evolocumab + Standard of Care | 2,391 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events2,525
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 | Bronchitis | Infections and infestations | Year 1: Standard of Care | 43 | 1,227 | |
| other | Bronchitis | Infections and infestations | Year 1: Evolocumab + Standard of Care | 78 | 2,454 | |
| other | Bronchitis | Infections and infestations | Years 2-3: SOC / Evolocumab + SOC | 70 | 1,197 | |
| other | Bronchitis | Infections and infestations | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 132 | 2,391 | |
| other | Bronchitis | Infections and infestations | Years 2-3: Total | 202 | 3,588 | |
| other | Influenza | Infections and infestations | Year 1: Standard of Care | 28 | 1,227 | |
| other | Influenza | Infections and infestations | Year 1: Evolocumab + Standard of Care | 66 | 2,454 | |
| other | Influenza | Infections and infestations | Years 2-3: SOC / Evolocumab + SOC | 60 | 1,197 | |
| other | Influenza | Infections and infestations | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 115 | 2,391 | |
| other | Influenza | Infections and infestations | Years 2-3: Total | 175 | 3,588 |
1 to 10 of 2,525Source ClinicalTrials.gov
See all 2,525 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Year 1: Standard of Care | 5 | 1,227 |
| Total, all-cause mortality | Year 1: Evolocumab + Standard of Care | 5 | 2,454 |
| Total, all-cause mortality | Years 2-3: SOC / Evolocumab + SOC | 5 | 1,197 |
| Total, all-cause mortality | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 16 | 2,391 |
| Total, all-cause mortality | Years 2-3: Total | 21 | 3,588 |
| Total, other adverse events | Year 1: Standard of Care | 334 | 1,227 |
| Total, other adverse events | Year 1: Evolocumab + Standard of Care | 681 | 2,454 |
| Total, other adverse events | Years 2-3: SOC / Evolocumab + SOC | 498 | 1,197 |
| Total, other adverse events | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 928 | 2,391 |
| Total, other adverse events | Years 2-3: Total | 1,426 | 3,588 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01854918
GET https://conductscience.org/api/trials/v1/NCT01854918/results?page=2