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NCT03080935

Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Terminated Phase 3 Results posted Last updated 29 May 2024
What this trial tests

Phase 3 trial testing Evolocumab in Dyslipidemia in 1,600 participants. Terminated before completion.

Timeline
13 March 2017
Primary endpoint
4 March 2022
4 March 2022

Quick facts

Lead sponsorAmgen
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment1,600
Start date13 March 2017
Primary completion4 March 2022
Estimated completion4 March 2022
Sites85 locations across Denmark, France, Italy, Belgium, Sweden, Germany, Portugal

Drugs / interventions tested

Conditions studied

Sponsor

Amgen — full company profile →

Who can join

Adults 40 to 85, any sex, with Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced an Adverse Event Primary · 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.

GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study686
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study810
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Secondary · Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Week 12
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-66.32± 26.88
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-67.24± 25.23
Week 24
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-66.48± 27.52
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-66.47± 28.11
Week 48
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-62.61± 26.60
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-63.45± 26.03
Week 72
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-65.58± 28.13
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-65.33± 28.42
Week 96
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-64.58± 27.01
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-63.43± 28.80
Week 120
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-64.26± 28.31
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-63.10± 29.56
Week 144
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-66.79± 29.22
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-65.13± 31.96
Week 168
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-65.28± 27.55
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study-63.55± 29.60
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Secondary · Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Baseline in parent study
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study00.0 – 0.5
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study00.0 – 0.4
Week 12
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study72.869.4 – 75.9
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study72.569.4 – 75.4
Week 24
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study72.969.5 – 76.0
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study73.470.3 – 76.2
Week 48
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study66.563.0 – 69.9
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study68.064.8 – 71.1
Week 72
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study73.269.8 – 76.3
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study72.369.1 – 75.2
Week 96
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study71.167.6 – 74.3
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study69.265.9 – 72.3
Week 120
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study70.967.5 – 74.2
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study68.665.3 – 71.8
Week 144
GroupValue95% CI
Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study75.371.2 – 78.9
Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study72.268.5 – 75.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo in Parent Study
Serious: 323/745 (43%)
Deaths: 35/745
Evolocumab in Parent Study
Serious: 410/854 (48%)
Deaths: 51/855

Serious adverse events (601 terms)

ReactionSystemPlacebo in Parent StudyEvolocumab in Parent Study
Cardiac failureCardiac disorders——
Angina pectorisCardiac disorders——
Atrial fibrillationCardiac disorders——
PneumoniaInfections and infestations——
Acute myocardial infarctionCardiac disorders——
Angina unstableCardiac disorders——
OsteoarthritisMusculoskeletal and connective tissue disorders——
Ischaemic strokeNervous system disorders——
Peripheral arterial occlusive diseaseVascular disorders——
Coronary artery stenosisCardiac disorders——
Coronary artery diseaseCardiac disorders——
Non-cardiac chest painGeneral disorders——
SyncopeNervous system disorders——
Myocardial infarctionCardiac disorders——
Cholecystitis acuteHepatobiliary disorders——
Transient ischaemic attackNervous system disorders——
Ventricular tachycardiaCardiac disorders——
Acute kidney injuryRenal and urinary disorders——
Acute coronary syndromeCardiac disorders——
Myocardial ischaemiaCardiac disorders——
Chest painGeneral disorders——
ErysipelasInfections and infestations——
Spinal stenosisMusculoskeletal and connective tissue disorders——
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders——
Other adverse events (15 terms — click to expand)

ReactionSystemPlacebo in Parent StudyEvolocumab in Parent Study
HypertensionVascular disorders——
NasopharyngitisInfections and infestations——
ArthralgiaMusculoskeletal and connective tissue disorders——
Back painMusculoskeletal and connective tissue disorders——
Diabetes mellitusMetabolism and nutrition disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
InfluenzaInfections and infestations——
Pain in extremityMusculoskeletal and connective tissue disorders——
Atrial fibrillationCardiac disorders——
BronchitisInfections and infestations——
DizzinessNervous system disorders——
CataractEye disorders——
PneumoniaInfections and infestations——
Chest painGeneral disorders——
CoughRespiratory, thoracic and mediastinal disorders——

Most-reported serious reactions: Cardiac failure, Angina pectoris, Atrial fibrillation, Pneumonia, Acute myocardial infarction, Angina unstable, Osteoarthritis, Ischaemic stroke.

Data from ClinicalTrials.gov NCT03080935 adverse events section.

Sponsor's own description

This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease.
    O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, et al · · 2022 · cited 268× · PMID 36031810 · DOI 10.1161/circulationaha.122.061620
  2. PCSK9 Inhibition: Insights From Clinical Trials and Future Prospects.
    Katzmann JL, Gouni-Berthold I, Laufs U. · · 2020 · cited 55× · PMID 33304274 · DOI 10.3389/fphys.2020.595819
  3. PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database.
    di Mauro G, Zinzi A, Scavone C, Mascolo A, et al · · 2021 · cited 32× · PMID 33351170 · DOI 10.1007/s40264-020-01021-3
  4. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2022.
    Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2023 · cited 25× · PMID 37169875 · DOI 10.1093/ehjcvp/pvad034
  5. The cGAS-STING pathway in cardiovascular diseases: from basic research to clinical perspectives.
    An C, Li Z, Chen Y, Huang S, et al · · 2024 · cited 22× · PMID 38720328 · DOI 10.1186/s13578-024-01242-4
  6. What Lessons Have We Learned and What Remains to be Clarified for PCSK9 Inhibitors? A Review of FOURIER and ODYSSEY Outcomes Trials.
    Furtado RHM, Giugliano RP. · · 2020 · cited 21× · PMID 32026310 · DOI 10.1007/s40119-020-00163-w
  7. Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update.
    Kaddoura R, Orabi B, Salam AM. · · 2020 · cited 18× · PMID 32939318 · DOI 10.1080/21556660.2020.1801452
  8. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment.
    Sugiyama K, Saisho Y. · · 2018 · cited 4× · PMID 29794992 · DOI 10.3390/diseases6020044

Verify or expand the search:

Other trials of Evolocumab

Trials testing the same drug.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03080935.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing