Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849497
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