Trial · NCT01588496
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
NCT01588496, Phase 2, Phase 3, Completed, Amgen; results first posted 2015-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities. Trials, record NCT01588496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01588496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
- NCT number
- NCT01588496
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- Evolocumab, Placebo
- First posted
- 2012-05-01
- Last updated
- 2018-11-29
- Other registries' IDs
- eudract:2011-005399-40
- Results first posted
- 2015-10-02
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | LDL-C was quantified using the ultracentrifugation method. |
| Primary | Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | LDL-C was quantified using the ultracentrifugation method. |
| Secondary | Part A: Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | LDL-C was quantified using the ultracentrifugation method. |
| Secondary | Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseline and Week 12 | |
| Secondary | Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | |
| Secondary | Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 | |
| Secondary | Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | Baseline and Week 12 | |
| Secondary | Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 | Baseline and Week 12 | LDL-C was quantified using the ultracentrifugation method. |
| Secondary | Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 | Baseline and Week 12 | |
| Secondary | Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 | Baseline and Weeks 6 and 12 | LDL-C was quantified using the ultracentrifugation method. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab) | percent change | MEAN |
| SECONDARY | Part A: Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | Part A full analysis set | mg/dL | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseline and Week 12 | Part A full analysis set | percent change | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | Part A full analysis set | percent change | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 | Part A full analysis set | percent change | MEAN |
| SECONDARY | Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | Baseline and Week 12 | Part A full analysis set | percent change | MEAN |
| SECONDARY | Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 | Baseline and Week 12 | Part A full analysis set | percentage of participants | NUMBER |
| SECONDARY | Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 | Baseline and Week 12 | Part A full analysis set | ng/mL | MEAN |
| SECONDARY | Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 | Baseline and Weeks 6 and 12 | Part B full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | Part B full analysis set | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Part A: Evolocumab | -16.5 | Standard Error 6.7 | percent change | |
| Part A: Change From Baseline in LDL-C at Week 12 | Part A: Evolocumab | -70.6 | Standard Error 32.3 | mg/dL | |
| Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Part A: Evolocumab | -16.6 | Standard Error 6.5 | percent change | |
| Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 | Part A: Evolocumab | -14.9 | Standard Error 5.0 | percent change | |
| Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Part A: Evolocumab | -18.319 | Standard Error 6.058 | percent change | |
| Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | Part A: Evolocumab | -15.65 | Standard Error 4.690 | percent change | |
| Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 | Part A: Evolocumab | 50.0 | percentage of participants | ||
| Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 | Part A: Evolocumab | -151.3 | Standard Error 81.7 | ng/mL | |
| Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 | Part B: Placebo | 4.22 | Standard Error 4.56 | percent change | |
| Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 | Part B: Evolocumab | -25.56 | Standard Error 3.28 | percent change |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Evolocumab | 8 | |
| Overall Study | STARTED | Part B: Placebo | 17 | |
| Overall Study | STARTED | Part B: Evolocumab | 33 | |
| Overall Study | Received Treatment | Part A: Evolocumab | 8 | |
| Overall Study | Received Treatment | Part B: Placebo | 16 | |
| Overall Study | Received Treatment | Part B: Evolocumab | 33 | |
| Overall Study | COMPLETED | Part A: Evolocumab | 8 | |
| Overall Study | COMPLETED | Part B: Placebo | 16 | |
| Overall Study | COMPLETED | Part B: Evolocumab | 33 | |
| Overall Study | NOT COMPLETED | Part A: Evolocumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events69
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 | Palpitations | Cardiac disorders | Part A: OL Evolocumab | 0 | 8 | |
| other | Palpitations | Cardiac disorders | Part B: DB Placebo | 1 | 16 | |
| other | Palpitations | Cardiac disorders | Part B: DB Evolocumab | 0 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: OL Evolocumab | 0 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: DB Placebo | 1 | 16 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: DB Evolocumab | 1 | 33 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part A: OL Evolocumab | 0 | 8 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part B: DB Placebo | 1 | 16 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part B: DB Evolocumab | 0 | 33 | |
| other | Dyspepsia | Gastrointestinal disorders | Part A: OL Evolocumab | 1 | 8 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: OL Evolocumab | ||
| Total, all-cause mortality | Part B: DB Placebo | ||
| Total, all-cause mortality | Part B: DB Evolocumab | ||
| Total, other adverse events | Part A: OL Evolocumab | 4 | 8 |
| Total, other adverse events | Part B: DB Placebo | 10 | 16 |
| Total, other adverse events | Part B: DB Evolocumab | 11 | 33 |
| Total, serious adverse events | Part A: OL Evolocumab | 0 | 8 |
| Total, serious adverse events | Part B: DB Placebo | 0 | 16 |
| Total, serious adverse events | Part B: DB Evolocumab | 0 | 33 |
Source ClinicalTrials.gov
Papers3
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/NCT01588496
GET https://conductscience.org/api/trials/v1/NCT01588496/events?page=2