A Phase 3 interventional study of Evolocumab and Placebo in Dyslipidemia, sponsored by Amgen. Completed at 1,284 sites in 49 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.
This study's enrollment of 27,564 is above the median of 100 across 861 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
Drug: Placebo
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.
Biological: Evolocumab
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Also known as: AMG 145, Repatha
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to All Cause Death
Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Myocardial Infarction
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: * Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and * Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Stroke
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Coronary Revascularization
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: 1. Admitted to hospital with a primary diagnosis of HF 2. In hospital for at least 24 hours 3. Documented new or worsening symptoms due to HF, including at least 1 of the following: * Dyspnea * Decreased exercise tolerance * Fatigue * Other symptoms of worsened end-organ perfusion or volume overload 4. Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion 5. Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Time frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Participants were enrolled at 1242 clinical centers in 49 countries in the regions of Europe (62.9%), North America (16.6%), Asia Pacific (13.9%), and Latin America (6.6%) from 08 February 2013 to 05 June 2015.
| Milestone | Placebo | Evolocumab |
|---|---|---|
| Started | 13780 | 13784 |
| Received treatment | 13756 | 13769 |
| Completed | 13662 | 13691 |
| Not completed | 118 | 93 |
| Withdrew: Withdrawal by subject | 105 | 88 |
| Withdrew: Lost to follow-up | 13 | 5 |
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 3.11 (2.82 to 3.40) | 2.74 (2.47 to 3.01) |
| KM estimate at 12 months | 6.01 (5.61 to 6.41) | 5.31 (4.93 to 5.68) |
| KM estimate at 18 months | 8.32 (7.86 to 8.78) | 7.25 (6.81 to 7.68) |
| KM estimate at 24 months | 10.66 (10.12 to 11.19) | 9.13 (8.63 to 9.63) |
| KM estimate at 30 months | 12.72 (12.08 to 13.35) | 10.91 (10.31 to 11.50) |
| KM estimate at 36 months | 14.64 (13.76 to 15.50) | 12.57 (11.70 to 13.42) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 1.86 (1.63 to 2.08) | 1.65 (1.44 to 1.86) |
| KM estimate at 12 months | 3.68 (3.36 to 3.99) | 3.10 (2.81 to 3.38) |
| KM estimate at 18 months | 5.18 (4.81 to 5.55) | 4.29 (3.95 to 4.62) |
| KM estimate at 24 months | 6.83 (6.39 to 7.26) | 5.47 (5.08 to 5.86) |
| KM estimate at 30 months | 8.31 (7.78 to 8.84) | 6.66 (6.19 to 7.14) |
| KM estimate at 36 months | 9.93 (9.16 to 10.69) | 7.90 (7.17 to 8.63) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 0.40 (0.29 to 0.50) | 0.39 (0.29 to 0.50) |
| KM estimate at 12 months | 0.82 (0.67 to 0.97) | 0.79 (0.64 to 0.94) |
| KM estimate at 18 months | 1.19 (1.01 to 1.37) | 1.20 (1.01 to 1.38) |
| KM estimate at 24 months | 1.57 (1.36 to 1.79) | 1.64 (1.42 to 1.85) |
| KM estimate at 30 months | 1.99 (1.72 to 2.26) | 2.11 (1.83 to 2.39) |
| KM estimate at 36 months | 2.39 (1.98 to 2.80) | 2.49 (2.09 to 2.88) |
Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 0.62 (0.49 to 0.75) | 0.55 (0.43 to 0.68) |
| KM estimate at 12 months | 1.29 (1.10 to 1.47) | 1.26 (1.07 to 1.44) |
| KM estimate at 18 months | 1.96 (1.73 to 2.19) | 1.94 (1.71 to 2.17) |
| KM estimate at 24 months | 2.78 (2.49 to 3.06) | 2.81 (2.52 to 3.10) |
| KM estimate at 30 months | 3.48 (3.12 to 3.83) | 3.63 (3.27 to 3.98) |
| KM estimate at 36 months | 4.28 (3.74 to 4.82) | 4.75 (4.16 to 5.34) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: * Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and * Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 1.14 (0.97 to 1.32) | 1.06 (0.88 to 1.23) |
| KM estimate at 12 months | 2.39 (2.13 to 2.64) | 1.90 (1.67 to 2.13) |
| KM estimate at 18 months | 3.33 (3.03 to 3.63) | 2.55 (2.28 to 2.81) |
| KM estimate at 24 months | 4.30 (3.95 to 4.65) | 3.21 (2.90 to 3.51) |
| KM estimate at 30 months | 5.25 (4.82 to 5.67) | 3.83 (3.47 to 4.19) |
| KM estimate at 36 months | 6.28 (5.67 to 6.89) | 4.41 (3.85 to 4.96) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 0.50 (0.38 to 0.61) | 0.31 (0.22 to 0.41) |
| KM estimate at 12 months | 0.85 (0.69 to 1.00) | 0.70 (0.56 to 0.84) |
| KM estimate at 18 months | 1.30 (1.11 to 1.50) | 1.05 (0.88 to 1.22) |
| KM estimate at 24 months | 1.80 (1.57 to 2.04) | 1.36 (1.16 to 1.56) |
| KM estimate at 30 months | 2.15 (1.88 to 2.43) | 1.71 (1.46 to 1.96) |
| KM estimate at 36 months | 2.60 (2.20 to 3.00) | 2.18 (1.76 to 2.59) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 1.87 (1.65 to 2.10) | 1.60 (1.39 to 1.81) |
| KM estimate at 12 months | 3.71 (3.39 to 4.02) | 3.13 (2.84 to 3.42) |
| KM estimate at 18 months | 5.20 (4.82 to 5.57) | 4.16 (3.83 to 4.50) |
| KM estimate at 24 months | 6.57 (6.14 to 7.00) | 5.22 (4.84 to 5.61) |
| KM estimate at 30 months | 7.91 (7.39 to 8.42) | 6.13 (5.68 to 6.58) |
| KM estimate at 36 months | 9.17 (8.46 to 9.87) | 7.01 (6.36 to 7.65) |
All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: 1. Admitted to hospital with a primary diagnosis of HF 2. In hospital for at least 24 hours 3. Documented new or worsening symptoms due to HF, including at least 1 of the following: * Dyspnea * Decreased exercise tolerance * Fatigue * Other symptoms of worsened end-organ perfusion or volume overload 4. Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion 5. Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 0.79 (0.64 to 0.93) | 0.64 (0.51 to 0.77) |
| KM estimate at 12 months | 1.35 (1.16 to 1.54) | 1.29 (1.10 to 1.48) |
| KM estimate at 18 months | 1.99 (1.75 to 2.22) | 1.99 (1.76 to 2.22) |
| KM estimate at 24 months | 2.70 (2.41 to 2.98) | 2.64 (2.36 to 2.92) |
| KM estimate at 30 months | 3.45 (3.09 to 3.81) | 3.31 (2.97 to 3.65) |
| KM estimate at 36 months | 4.03 (3.50 to 4.55) | 4.13 (3.57 to 4.68) |
All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
| percentage of participants | Placebo | Evolocumab |
|---|---|---|
| KM estimate at 6 months | 0.61 (0.48 to 0.73) | 0.42 (0.31 to 0.53) |
| KM estimate at 12 months | 1.05 (0.88 to 1.22) | 0.83 (0.67 to 0.98) |
| KM estimate at 18 months | 1.52 (1.32 to 1.73) | 1.18 (1.00 to 1.37) |
| KM estimate at 24 months | 2.05 (1.81 to 2.30) | 1.46 (1.25 to 1.66) |
| KM estimate at 30 months | 2.40 (2.11 to 2.68) | 1.92 (1.65 to 2.19) |
| KM estimate at 36 months | 2.81 (2.41 to 3.21) | 2.48 (2.01 to 2.95) |
Collected over From the first dose of study drug to the end of study. The median duration of follow-up was 26 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 3,404/13,756 (24.7%) | 3,438/13,756 (25%) |
| Evolocumab | — | 3,410/13,769 (24.8%) | 3,500/13,769 (25.4%) |
| Event | Placebo | Evolocumab |
|---|---|---|
| Angina unstableCardiac disorders | 278/13756 | 233/13769 |
| Angina pectorisCardiac disorders | 221/13756 | 208/13769 |
| PneumoniaInfections and infestations | 152/13756 | 147/13769 |
| Non-cardiac chest painGeneral disorders | 133/13756 | 109/13769 |
| Atrial fibrillationCardiac disorders | 132/13756 | 119/13769 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 100/13756 | 91/13769 |
| Peripheral arterial occlusive diseaseVascular disorders | 82/13756 | 94/13769 |
| Cardiac failureCardiac disorders | 66/13756 | 66/13769 |
| Acute kidney injuryRenal and urinary disorders | 64/13756 | 64/13769 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 64/13756 | 64/13769 |
| Event | Placebo | Evolocumab |
|---|---|---|
| HypertensionVascular disorders | 1157/13756 | 1069/13769 |
| Diabetes mellitusMetabolism and nutrition disorders | 1096/13756 | 1156/13769 |
| NasopharyngitisInfections and infestations | 1021/13756 | 1067/13769 |
| Upper respiratory tract infectionInfections and infestations | 649/13756 | 692/13769 |
| Age, Continuous(years) | Placebo | Evolocumab | Total |
|---|---|---|---|
| Mean | 62.5 ± 8.9 | 62.5 ± 9.1 | 62.5 ± 9.0 |
| Age, Customized(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| < 65 years | 7687 | 7623 | 15310 |
| ≥ 65 years | 6093 | 6161 | 12254 |
| Sex: Female, Male(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| Female | 3382 | 3387 | 6769 |
| Male | 10398 | 10397 | 20795 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| Hispanic or Latino | 1084 | 1093 | 2177 |
| Not Hispanic or Latino | 12694 | 12688 | 25382 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Race/Ethnicity, Customized(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 80 | 60 | 140 |
| Asian | 1349 | 1374 | 2723 |
| Black or African American | 352 | 317 | 669 |
| Native Hawaiian or Other Pacific Islander | 11 | 15 | 26 |
| White | 11710 | 11748 | 23458 |
| Multiple | 12 | 19 | 31 |
| Other | 266 | 251 | 517 |
| Low-density Lipoprotein Cholesterol(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| < 85 mg/dL | 4803 | 4809 | 9612 |
| ≥ 85 mg/dL | 8977 | 8975 | 17952 |
| Geographical Region(Participants) | Placebo | Evolocumab | Total |
|---|---|---|---|
| Europe | 8669 | 8667 | 17336 |
| North America | 2284 | 2286 | 4570 |
| Latin America | 910 | 913 | 1823 |
| Asia Pacific | 1917 | 1918 | 3835 |
Showing the first 100 of 1,284 sites across 49 countries.
Ran from Feb 2013 to primary completion in Nov 2016, 45 months.
Results were first posted in Feb 2018, 1 year 3 months after primary completion. A results delay was requested in Jun 2017.
Of 55 industry-sponsored phase 3 interventional studies under Dyslipidemias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 45 months is above that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evolocumab