Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
|ClinicalTrials.gov Identifier: NCT01879319|
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Primary Hypercholesterolemia Mixed Dyslipidemia||Biological: Evolocumab AMD Biological: Evolocumab AI/pen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Evolocumab AMD
Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
Biological: Evolocumab AMD
Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
Experimental: Evolocumab AI/pen
Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
Biological: Evolocumab AI/pen
Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
- Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 [ Time Frame: 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.
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879319
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