Trial · NCT02624869
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
NCT02624869, Phase 3, Completed, Amgen; results first posted 2022-01-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia). Trials, record NCT02624869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02624869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
- NCT number
- NCT02624869
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 163 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Familial Hypercholesterolemia
- Interventions
- Evolocumab
- First posted
- 2015-12-09
- Last updated
- 2024-05-29
- Other registries' IDs
- eudract:2015-002276-25
- Results first posted
- 2022-01-14
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. | An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE. |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
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 Treatment-emergent Adverse Events (TEAEs) | From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants | Baseline and week 80 | Full analysis set with available data | percent change | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group138
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 Treatment-emergent Adverse Events (TEAEs) | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | Any treatment-emergent adverse event (TEAE) | 36 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | Any treatment-emergent adverse event (TEAE) | 69 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HoFH: Evolocumab 420 mg QM | Any treatment-emergent adverse event (TEAE) | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | TEAE ≥ Grade 2 | 25 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | TEAE ≥ Grade 2 | 56 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HoFH: Evolocumab 420 mg QM | TEAE ≥ Grade 2 | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | TEAE ≥ Grade 3 | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | TEAE ≥ Grade 3 | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HoFH: Evolocumab 420 mg QM | TEAE ≥ Grade 3 | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | TEAE ≥ Grade 4 | 0 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 49 | |
| Overall Study | STARTED | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 101 | |
| Overall Study | STARTED | HoFH: Evolocumab 420 mg QM | 13 | |
| Overall Study | Received Study Drug | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 49 | |
| Overall Study | Received Study Drug | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 101 | |
| Overall Study | Received Study Drug | HoFH: Evolocumab 420 mg QM | 12 | |
| Overall Study | COMPLETED | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 48 | |
| Overall Study | COMPLETED | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 98 | |
| Overall Study | COMPLETED | HoFH: Evolocumab 420 mg QM | 11 | |
| Overall Study | NOT COMPLETED | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events87
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 | Abdominal pain upper | Gastrointestinal disorders | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 1 | 49 | |
| other | Abdominal pain upper | Gastrointestinal disorders | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 5 | 101 | |
| other | Abdominal pain upper | Gastrointestinal disorders | HoFH: Evolocumab 420 mg QM | 1 | 12 | |
| other | Nausea | Gastrointestinal disorders | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 0 | 49 | |
| other | Nausea | Gastrointestinal disorders | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 1 | 101 | |
| other | Nausea | Gastrointestinal disorders | HoFH: Evolocumab 420 mg QM | 1 | 12 | |
| other | Fatigue | General disorders | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 4 | 49 | |
| other | Fatigue | General disorders | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 3 | 101 | |
| other | Fatigue | General disorders | HoFH: Evolocumab 420 mg QM | 0 | 12 | |
| other | Influenza like illness | General disorders | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 5 | 49 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 0 | 49 |
| Total, all-cause mortality | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 0 | 101 |
| Total, all-cause mortality | HoFH: Evolocumab 420 mg QM | 0 | 13 |
| Total, other adverse events | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 27 | 49 |
| Total, other adverse events | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 45 | 101 |
| Total, other adverse events | HoFH: Evolocumab 420 mg QM | 7 | 12 |
| Total, serious adverse events | HeFH (Placebo in Parent Study): Evolocumab 420 mg QM | 2 | 49 |
| Total, serious adverse events | HeFH (Evolocumab in Parent Study): Evolocumab 420 mg QM | 2 | 101 |
| Total, serious adverse events | HoFH: Evolocumab 420 mg QM | 2 | 12 |
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 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/NCT02624869
GET https://conductscience.org/api/trials/v1/NCT02624869/registered?page=2