Trial · NCT01624142
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
NCT01624142, Phase 2, Phase 3, Completed, Amgen; results first posted 2019-01-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders. Trials, record NCT01624142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01624142
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
- NCT number
- NCT01624142
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Severe Familial Hypercholesterolemia
- Interventions
- Evolocumab
- First posted
- 2012-06-20
- Last updated
- 2024-05-28
- Other registries' IDs
- eudract:2011-005400-15
- Results first posted
- 2019-01-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. | The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, 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 Low-density Lipoprotein Cholesterol (LDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percent Change From Baseline in Lipoprotein (a) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | |
| Secondary | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 |
Source ClinicalTrials.gov
Outcomes8
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 | From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. | All participants who received at least one dose of evolocumab in Study 20110271 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein (a) | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With a 15% or Greater Reduction in LDL-C | Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216 | Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group338
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 | HoFH | All adverse events (AEs) | 94 | Participants | |
| Number of Participants With Adverse Events | Severe FH | All adverse events (AEs) | 174 | Participants | |
| Number of Participants With Adverse Events | HoFH | Adverse events ≥ grade 2 | 76 | Participants | |
| Number of Participants With Adverse Events | Severe FH | Adverse events ≥ grade 2 | 143 | Participants | |
| Number of Participants With Adverse Events | HoFH | Adverse events ≥ grade 3 | 38 | Participants | |
| Number of Participants With Adverse Events | Severe FH | Adverse events ≥ grade 3 | 68 | Participants | |
| Number of Participants With Adverse Events | HoFH | Adverse events ≥ grade 4 | 4 | Participants | |
| Number of Participants With Adverse Events | Severe FH | Adverse events ≥ grade 4 | 14 | Participants | |
| Number of Participants With Adverse Events | HoFH | Serious adverse events (SAEs) | 29 | Participants | |
| Number of Participants With Adverse Events | Severe FH | Serious adverse events (SAEs) | 57 | Participants |
1 to 10 of 338Source ClinicalTrials.gov
See all 338 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HoFH | 106 | |
| Overall Study | STARTED | Severe FH | 194 | |
| Overall Study | COMPLETED | HoFH | 74 | |
| Overall Study | COMPLETED | Severe FH | 178 | |
| Overall Study | NOT COMPLETED | HoFH | 32 | |
| Overall Study | NOT COMPLETED | Severe FH | 16 |
Source ClinicalTrials.gov
Adverse events399
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 | Gastrointestinal disorders | HoFH | 7 | 106 | |
| other | Abdominal pain | Gastrointestinal disorders | Severe FH | 7 | 194 | |
| other | Abdominal pain | Gastrointestinal disorders | Total | 14 | 300 | |
| other | Diarrhoea | Gastrointestinal disorders | HoFH | 7 | 106 | |
| other | Diarrhoea | Gastrointestinal disorders | Severe FH | 22 | 194 | |
| other | Diarrhoea | Gastrointestinal disorders | Total | 29 | 300 | |
| other | Chest pain | General disorders | HoFH | 4 | 106 | |
| other | Chest pain | General disorders | Severe FH | 15 | 194 | |
| other | Chest pain | General disorders | Total | 19 | 300 | |
| other | Fatigue | General disorders | HoFH | 8 | 106 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HoFH | 3 | 106 |
| Total, all-cause mortality | Severe FH | 6 | 194 |
| Total, all-cause mortality | Total | 9 | 300 |
| Total, other adverse events | HoFH | 80 | 106 |
| Total, other adverse events | Severe FH | 134 | 194 |
| Total, other adverse events | Total | 214 | 300 |
| Total, serious adverse events | HoFH | 29 | 106 |
| Total, serious adverse events | Severe FH | 57 | 194 |
| Total, serious adverse events | Total | 86 | 300 |
Source ClinicalTrials.gov
Papers6
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/NCT01624142
GET https://conductscience.org/api/trials/v1/NCT01624142/results?page=2