Trial · NCT01763866
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
NCT01763866, Phase 3, Completed, Amgen; results first posted 2015-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2. Trials, record NCT01763866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01763866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
- NCT number
- NCT01763866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,067 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperlipidemia
- Interventions
- Evolocumab, Ezetimibe, Placebo to Evolocumab, Placebo to Ezetimibe, Atorvastatin, Rosuvastatin, Simvastatin
- First posted
- 2013-01-09
- Last updated
- 2022-11-08
- Other registries' IDs
- eudract:2012-001363-70
- Results first posted
- 2015-12-22
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | |
| Primary | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | Full analysis set | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group528
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 PBO Q2W | 9.86 | Standard Error 2.53 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 PBO QM | 0.97 | Standard Error 2.82 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 EZE (Q2W) | -21.96 | Standard Error 2.63 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 EZE (QM) | -17.08 | Standard Error 2.78 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 EvoMab Q2W | -61.56 | Standard Error 1.81 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A10 EvoMab QM | -58.19 | Standard Error 1.99 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A80 PBO Q2W | 14.49 | Standard Error 4.42 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A80 PBO QM | 11.83 | Standard Error 3.85 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A80 EZE (Q2W) | -14.60 | Standard Error 4.29 | percent change | |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | A80 EZE (QM) | -19.80 | Standard Error 3.85 | percent change |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 results by groupParticipant flow96
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A10 PBO Q2W | 56 | |
| Overall Study | STARTED | A10 PBO QM | 55 | |
| Overall Study | STARTED | A10 EZE (Q2W) | 56 | |
| Overall Study | STARTED | A10 EZE (QM) | 55 | |
| Overall Study | STARTED | A10 EvoMab Q2W | 110 | |
| Overall Study | STARTED | A10 EvoMab QM | 110 | |
| Overall Study | STARTED | A80 PBO Q2W | 55 | |
| Overall Study | STARTED | A80 PBO QM | 55 | |
| Overall Study | STARTED | A80 EZE (Q2W) | 56 | |
| Overall Study | STARTED | A80 EZE (QM) | 54 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 participant flowAdverse events1,200
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 | Constipation | Gastrointestinal disorders | A10 PBO Q2W | 3 | 56 | |
| other | Constipation | Gastrointestinal disorders | A10 PBO QM | 0 | 55 | |
| other | Constipation | Gastrointestinal disorders | A10 EZE (Q2W) | 0 | 56 | |
| other | Constipation | Gastrointestinal disorders | A10 EZE (QM) | 0 | 55 | |
| other | Constipation | Gastrointestinal disorders | A10 EvoMab Q2W | 0 | 110 | |
| other | Constipation | Gastrointestinal disorders | A10 EvoMab QM | 0 | 110 | |
| other | Constipation | Gastrointestinal disorders | A80 PBO Q2W | 1 | 55 | |
| other | Constipation | Gastrointestinal disorders | A80 PBO QM | 0 | 55 | |
| other | Constipation | Gastrointestinal disorders | A80 EZE (Q2W) | 1 | 56 | |
| other | Constipation | Gastrointestinal disorders | A80 EZE (QM) | 0 | 54 |
1 to 10 of 1,200Source ClinicalTrials.gov
See all 1,200 adverse eventsAdverse event totals72
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A10 PBO Q2W | ||
| Total, all-cause mortality | A10 PBO QM | ||
| Total, all-cause mortality | A10 EZE (Q2W) | ||
| Total, all-cause mortality | A10 EZE (QM) | ||
| Total, all-cause mortality | A10 EvoMab Q2W | ||
| Total, all-cause mortality | A10 EvoMab QM | ||
| Total, all-cause mortality | A80 PBO Q2W | ||
| Total, all-cause mortality | A80 PBO QM | ||
| Total, all-cause mortality | A80 EZE (Q2W) | ||
| Total, all-cause mortality | A80 EZE (QM) |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse event totalsPapers12
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/NCT01763866
GET https://conductscience.org/api/trials/v1/NCT01763866/registered?page=2