Trial · NCT03080935
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
NCT03080935, Phase 3, Terminated, Amgen; results first posted 2023-01-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries. Trials, record NCT03080935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03080935
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
- NCT number
- NCT03080935
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,600 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Dyslipidemia
- Interventions
- Evolocumab
- First posted
- 2017-03-15
- Last updated
- 2024-05-29
- Other registries' IDs
- eudract:2016-004066-26
- Results first posted
- 2023-01-11
- Limitations and caveats
- This study was terminated to coincide with the completion of study 20130295 (NCT02867813). The study was not terminated due to any safety findings.
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 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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 group48
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 Every Month (QM) in Parent Study | 686 | Participants | ||
| Number of Participants Who Experienced an Adverse Event | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 810 | Participants | ||
| Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Week 12 | -66.32 | Standard Deviation 26.88 | 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 Every Month (QM) in Parent Study | Week 12 | -67.24 | Standard Deviation 25.23 | 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 Every Month (QM) in Parent Study | Week 24 | -66.48 | Standard Deviation 27.52 | 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 Every Month (QM) in Parent Study | Week 24 | -66.47 | Standard Deviation 28.11 | 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 Every Month (QM) in Parent Study | Week 48 | -62.61 | Standard Deviation 26.60 | 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 Every Month (QM) in Parent Study | Week 48 | -63.45 | Standard Deviation 26.03 | 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 Every Month (QM) in Parent Study | Week 72 | -65.58 | Standard Deviation 28.13 | 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 Every Month (QM) in Parent Study | Week 72 | -65.33 | Standard Deviation 28.42 | Percent Change |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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 Every Month (QM) in Parent Study | 745 | |
| Overall Study | STARTED | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 855 | |
| Overall Study | COMPLETED | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 695 | |
| Overall Study | COMPLETED | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 786 | |
| Overall Study | NOT COMPLETED | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 50 | |
| Overall Study | NOT COMPLETED | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | 69 |
Source ClinicalTrials.gov
Adverse events1,232
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 | Atrial fibrillation | Cardiac disorders | Placebo in Parent Study | 37 | 745 | |
| other | Atrial fibrillation | Cardiac disorders | Evolocumab in Parent Study | 49 | 854 | |
| other | Cataract | Eye disorders | Placebo in Parent Study | 42 | 745 | |
| other | Cataract | Eye disorders | Evolocumab in Parent Study | 32 | 854 | |
| other | Chest pain | General disorders | Placebo in Parent Study | 40 | 745 | |
| other | Chest pain | General disorders | Evolocumab in Parent Study | 29 | 854 | |
| other | Bronchitis | Infections and infestations | Placebo in Parent Study | 32 | 745 | |
| other | Bronchitis | Infections and infestations | Evolocumab in Parent Study | 43 | 854 | |
| other | Influenza | Infections and infestations | Placebo in Parent Study | 37 | 745 | |
| other | Influenza | Infections and infestations | Evolocumab in Parent Study | 53 | 854 |
1 to 10 of 1,232Source ClinicalTrials.gov
See all 1,232 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 | 35 | 745 |
| Total, all-cause mortality | Evolocumab in Parent Study | 51 | 855 |
| Total, other adverse events | Placebo in Parent Study | 451 | 745 |
| Total, other adverse events | Evolocumab in Parent Study | 528 | 854 |
| Total, serious adverse events | Placebo in Parent Study | 323 | 745 |
| Total, serious adverse events | Evolocumab in Parent Study | 410 | 854 |
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 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 Every Month (QM) in Parent Study vs Placebo Once Every 2 Weeks (Q2W) or Once Every 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/NCT03080935
GET https://conductscience.org/api/trials/v1/NCT03080935/results?page=2