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Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01849497
First received: April 1, 2013
Last updated: September 11, 2015
Last verified: September 2015

April 1, 2013
September 11, 2015
April 2013
September 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 [ Time Frame: Week 2 and Week 4 ] [ Designated as safety issue: No ]
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.
Combination of subject reported outcomes across two attempted full-dose administrations of AMG 145 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The administration outcomes of each planned administration at weeks 2 and 4 will be combined for each subject. The proportion of subjects with each combination of outcomes at weeks 2 and 4 will be estimated by treatment group.
Complete list of historical versions of study NCT01849497 on ClinicalTrials.gov Archive Site
Percent Change From Baseline in LDL-C at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Percent Change From Baseline in LDL-C at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Mean percent change from baseline in low density lipoprotein-cholesterol
Not Provided
Not Provided
 
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Hypercholesterolemia
  • Mixed Dyslipidemia
  • Biological: Evolocumab Pre-filled Syringe
    Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
    Other Names:
    • AMG 145
    • Repatha
  • Biological: Evolocumab AI/pen
    Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
    Other Names:
    • AMG 145
    • Repatha
  • 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.
    Intervention: Biological: Evolocumab 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.
    Intervention: Biological: Evolocumab AI/pen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01849497
20120348
No
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP