Primary Hypercholesterolemia Clinical Trial
Official title:
A Multicenter, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.
| NCT number | NCT01879319 |
| Other study ID # | 20120356 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | July 11, 2013 |
| Verified date | November 2022 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
| Status | Completed |
| Enrollment | 164 |
| Est. completion date | |
| Est. primary completion date | November 15, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Fasting LDL-C at screening > 85 mg/dL - Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria: - New York Heart Association (NYHA) III or IV heart failure - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Type 1 diabetes or poorly controlled type 2 diabetes - Uncontrolled hypothyroidism or hyperthyroidism |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Research Site | Burnaby | British Columbia |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Pointe-Claire | Quebec |
| Canada | Research Site | Sarnia | Ontario |
| Canada | Research Site | Toronto | Ontario |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Ayer | Massachusetts |
| United States | Research Site | Cadiz | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Encino | California |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Lansdale | Pennsylvania |
| United States | Research Site | Lewiston | Maine |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Manlius | New York |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Saint Augustine | Florida |
| United States | Research Site | Thousand Oaks | California |
| United States | Research Site | Tustin | California |
| United States | Research Site | Ventura | California |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Canada,
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. — View Citation
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. — View Citation
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. — View Citation
Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 | Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window. | Weeks 4 and 8 | |
| Secondary | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
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