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The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab PFS | Experimental | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
|
| Evolocumab AI/pen | Experimental | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab Pre-filled Syringe | Biological | Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. | Week 2 and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Encino | California | 91436 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28717862 | Background | Boccara F, Dent R, Ruilope L, Valensi P. Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia. Adv Ther. 2017 Aug;34(8):1876-1896. doi: 10.1007/s12325-017-0586-8. Epub 2017 Jul 17. | |
| 28249876 | Background | Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Randomization was stratified on the basis of screening LDL-C concentration (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.
Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks.
The first patient enrolled on 18 April 2013 and last patient enrolled on 05 August 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evolocumab PFS | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Evolocumab AI/pen | Biological | Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen. |
|
|
| Thousand Oaks |
| California |
| 91360 |
| United States |
| Research Site | Ventura | California | 93003 | United States |
| Research Site | Westlake Village | California | 91361 | United States |
| Research Site | Miami | Florida | 33173 | United States |
| Research Site | Port Charlotte | Florida | 33952 | United States |
| Research Site | Atlanta | Georgia | 30328 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Hammond | Indiana | 46320 | United States |
| Research Site | Auburn | Maine | 04210 | United States |
| Research Site | Manlius | New York | 13104 | United States |
| Research Site | Syracuse | New York | 13210 | United States |
| Research Site | Cadiz | Ohio | 43907 | United States |
| Research Site | Marion | Ohio | 43302 | United States |
| Research Site | Hillsboro | Oregon | 97123 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Lansdale | Pennsylvania | 19446 | United States |
| Research Site | Rapid City | South Dakota | 57701 | United States |
| Research Site | Jackson | Tennessee | 38305 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | London | Ontario | N5W 6A2 | Canada |
| Research Site | Toronto | Ontario | M8V 3X8 | Canada |
| Research Site | Toronto | Ontario | M9V 4B4 | Canada |
| Research Site | Woodstock | Ontario | N4S 5P5 | Canada |
| Research Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| 29353350 | Background | Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. |
| 27066336 | Derived | Dent R, Joshi R, Stephen Djedjos C, Legg J, Elliott M, Geller M, Meyer D, Somaratne R, Recknor C, Weiss R. Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting. Springerplus. 2016 Mar 9;5:300. doi: 10.1186/s40064-016-1892-3. eCollection 2016. |
| Evolocumab AI/Pen |
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (all randomized participants who received at least 1 dose of study drug).
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| ID | Title | Description |
|---|---|---|
| BG000 | Evolocumab PFS | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). |
| BG001 | Evolocumab AI/Pen | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Stratification Factor: LDL-C Level | Number | participants |
| ||||||||||||||||
| LDL-C Concentration | Mean | Standard Deviation | mg/dL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 and Week 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in LDL-C at Week 6 | Full analysis set | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 6 |
|
|
From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evolocumab PFS | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). | 3 | 75 | 4 | 75 | ||
| EG001 | Evolocumab AI/Pen | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). | 2 | 74 | 2 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Glomerulonephritis minimal lesion | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Missing |
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| Not Hispanic or Latino |
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| ≥ 130 mg/dL |
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