Trial · NCT02867813
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
NCT02867813, Phase 3, Completed, Amgen; results first posted 2023-02-28
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension. Trials, record NCT02867813. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02867813
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
- NCT number
- NCT02867813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,035 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Dyslipidemia
- Interventions
- Evolocumab
- First posted
- 2016-08-16
- Last updated
- 2023-04-07
- Other registries' IDs
- eudract:2015-004780-36
- Results first posted
- 2023-02-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | Up to 5 years | All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events. |
| Secondary | Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 | |
| Secondary | Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced an Adverse Event | Up to 5 years | OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 | OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study. | Percent Change | MEAN |
| SECONDARY | Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 | OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2144 | Participants | ||
| Number of Participants Who Experienced an Adverse Event | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2084 | Participants | ||
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 12 | -55.93 | Standard Deviation 33.73 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 12 | -58.43 | Standard Deviation 30.64 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 24 | -56.69 | Standard Deviation 33.58 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 24 | -58.38 | Standard Deviation 31.52 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 48 | -58.52 | Standard Deviation 33.66 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 48 | -59.05 | Standard Deviation 33.06 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 72 | -56.35 | Standard Deviation 33.73 | Percent Change |
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Week 72 | -56.90 | Standard Deviation 33.14 | Percent Change |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2,535 | |
| Overall Study | STARTED | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2,500 | |
| Overall Study | COMPLETED | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2,084 | |
| Overall Study | COMPLETED | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 2,090 | |
| Overall Study | NOT COMPLETED | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 451 | |
| Overall Study | NOT COMPLETED | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 410 |
Source ClinicalTrials.gov
Adverse events1,940
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 | Bronchitis | Infections and infestations | Placebo in Parent Study | 162 | 2,532 | |
| other | Bronchitis | Infections and infestations | Evolocumab in Parent Study | 173 | 2,499 | |
| other | Nasopharyngitis | Infections and infestations | Placebo in Parent Study | 157 | 2,532 | |
| other | Nasopharyngitis | Infections and infestations | Evolocumab in Parent Study | 156 | 2,499 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo in Parent Study | 208 | 2,532 | |
| other | Upper respiratory tract infection | Infections and infestations | Evolocumab in Parent Study | 162 | 2,499 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Placebo in Parent Study | 139 | 2,532 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Evolocumab in Parent Study | 135 | 2,499 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo in Parent Study | 144 | 2,532 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Evolocumab in Parent Study | 138 | 2,499 |
1 to 10 of 1,940Source ClinicalTrials.gov
See all 1,940 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo in Parent Study | 309 | 2,535 |
| Total, all-cause mortality | Evolocumab in Parent Study | 287 | 2,500 |
| Total, other adverse events | Placebo in Parent Study | 956 | 2,532 |
| Total, other adverse events | Evolocumab in Parent Study | 959 | 2,499 |
| Total, serious adverse events | Placebo in Parent Study | 1,077 | 2,532 |
| Total, serious adverse events | Evolocumab in Parent Study | 1,045 | 2,499 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study vs Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study: Number of Participants Who Experienced an Adverse Event | Trial comparisons |
| Evolocumab in Parent Study vs Placebo in Parent Study: deaths from any cause | Trial comparisons |
| Evolocumab in Parent Study vs Placebo in Parent Study: serious adverse events | 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/NCT02867813
GET https://conductscience.org/api/trials/v1/NCT02867813/results?page=2