Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
|ClinicalTrials.gov Identifier: NCT01849497|
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : October 9, 2015
Last Update Posted : October 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Primary Hypercholesterolemia Mixed Dyslipidemia||Biological: Evolocumab Pre-filled Syringe Biological: Evolocumab AI/pen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, 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 Prefilled Syringe or a Prefilled Autoinjector/Pen|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: 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.
Biological: Evolocumab Pre-filled Syringe
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
Experimental: 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.
Biological: Evolocumab AI/pen
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
- Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 [ Time Frame: Week 2 and Week 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.
- Percent Change From Baseline in LDL-C at Week 6 [ Time Frame: Baseline and Week 6 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849497
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