Trial · NCT01516879
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
NCT01516879, Phase 3, Completed, Amgen; results first posted 2015-09-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study. Trials, record NCT01516879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01516879
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
- NCT number
- NCT01516879
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 905 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hypercholesterolemia
- Interventions
- Evolocumab, Placebo, Atorvastatin, Ezetimibe, Diet Only
- First posted
- 2012-01-25
- Last updated
- 2022-07-22
- Results first posted
- 2015-09-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C at Week 52 | Baseline and Week 52 | Cholesterol was measured by means of ultracentrifugation. |
| Secondary | Change From Baseline in LDL-C at Week 52 | Baseline and Week 52 | Cholesterol was measured by means of ultracentrifugation. |
| Secondary | Percentage of Participants With an LDL-C Response at Week 52 | Week 52 | An LDL-C response is defined as LDL-C level \< 70 mg/dL (1.8 mmol/L) at Week 52. |
| Secondary | Percent Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | Cholesterol was measured by means of ultracentrifugation. |
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 | |
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 52 | Baseline and Week 52 | |
| Secondary | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52 | Baseline and Week 52 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 52 | Baseline and Week 52 | |
| Secondary | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52 | Baseline and Week 52 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52 | Baseline and Week 52 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 LDL-C at Week 52 | Baseline and Week 52 | Full Analysis Set (all randomized subjects who received at least 1 dose of study drug). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in LDL-C at Week 52 | Baseline and Week 52 | Full Analysis Set | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With an LDL-C Response at Week 52 | Week 52 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | Full Analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol at Week 52 | Baseline and Week 52 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52 | Baseline and Week 52 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B at Week 52 | Baseline and Week 52 | Full analysis set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52 | Baseline and Week 52 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52 | Baseline and Week 52 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
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 LDL-C at Week 52 | Placebo | 6.83 | Standard Error 1.75 | percent change | |
| Percent Change From Baseline in LDL-C at Week 52 | Evolocumab | -50.14 | Standard Error 1.24 | percent change | |
| Change From Baseline in LDL-C at Week 52 | Placebo | 5.1 | Standard Error 1.9 | mg/dL | |
| Change From Baseline in LDL-C at Week 52 | Evolocumab | -52.7 | Standard Error 1.4 | mg/dL | |
| Percentage of Participants With an LDL-C Response at Week 52 | Placebo | 6.4 | 95% Confidence Interval 4.1 to 10.1 | percentage of participants | |
| Percentage of Participants With an LDL-C Response at Week 52 | Evolocumab | 82.3 | 95% Confidence Interval 78.8 to 85.3 | percentage of participants | |
| Percent Change From Baseline in LDL-C at Week 12 | Placebo | 3.17 | Standard Error 1.31 | percent change | |
| Percent Change From Baseline in LDL-C at Week 12 | Evolocumab | -54.35 | Standard Error 0.96 | percent change | |
| Percent Change From Baseline in Total Cholesterol at Week 12 | Placebo | 2.85 | Standard Error 0.87 | percent change | |
| Percent Change From Baseline in Total Cholesterol at Week 12 | Evolocumab | -32.30 | Standard Error 0.63 | percent change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 303 | |
| Overall Study | STARTED | Evolocumab | 602 | |
| Overall Study | Received Treatment | Placebo | 302 | |
| Overall Study | Received Treatment | Evolocumab | 599 | |
| Overall Study | COMPLETED | Placebo | 287 | |
| Overall Study | COMPLETED | Evolocumab | 568 | |
| Overall Study | NOT COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Evolocumab | 34 |
Source ClinicalTrials.gov
Adverse events104
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 | Influenza | Infections and infestations | Placebo | 19 | 302 | |
| other | Influenza | Infections and infestations | Evolocumab | 45 | 599 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 29 | 302 | |
| other | Nasopharyngitis | Infections and infestations | Evolocumab | 63 | 599 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 19 | 302 | |
| other | Upper respiratory tract infection | Infections and infestations | Evolocumab | 56 | 599 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 17 | 302 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Evolocumab | 36 | 599 | |
| serious | Angina pectoris | Cardiac disorders | Placebo | 2 | 302 | |
| serious | Angina pectoris | Cardiac disorders | Evolocumab | 2 | 599 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Evolocumab | ||
| Total, other adverse events | Placebo | 76 | 302 |
| Total, other adverse events | Evolocumab | 177 | 599 |
| Total, serious adverse events | Placebo | 13 | 302 |
| Total, serious adverse events | Evolocumab | 33 | 599 |
Source ClinicalTrials.gov
Papers12
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Evolocumab vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01516879
GET https://conductscience.org/api/trials/v1/NCT01516879/results?page=2