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
  Purpose
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.

Condition Intervention Phase
Primary Hypercholesterolemia
Mixed Dyslipidemia
Biological: Evolocumab Pre-filled Syringe
Biological: Evolocumab AI/pen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Percent Change From Baseline in LDL-C at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: April 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • AMG 145
  • Repatha
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.
Other Names:
  • AMG 145
  • Repatha

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849497

  Hide Study Locations
Locations
United States, California
Research Site
Encino, California, United States, 91436
Research Site
Thousand Oaks, California, United States, 91360
Research Site
Ventura, California, United States, 93003
Research Site
Westlake Village, California, United States, 91361
United States, Florida
Research Site
Miami, Florida, United States, 33173
Research Site
Port Charlotte, Florida, United States, 33952
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30342
Research Site
Atlanta, Georgia, United States, 30328
United States, Indiana
Research Site
Hammond, Indiana, United States, 46320
United States, Maine
Research Site
Auburn, Maine, United States, 04210
United States, New York
Research Site
Manlius, New York, United States, 13104
Research Site
Syracuse, New York, United States, 13210
United States, Ohio
Research Site
Cadiz, Ohio, United States, 43907
Research Site
Marion, Ohio, United States, 43302
United States, Oregon
Research Site
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Research Site
Lansdale, Pennsylvania, United States, 19446
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Research Site
Jackson, Tennessee, United States, 38305
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Research Site
Houston, Texas, United States, 77074
Canada, Ontario
Research Site
London, Ontario, Canada, N5W 6A2
Research Site
Toronto, Ontario, Canada, M8V 3X8
Research Site
Toronto, Ontario, Canada, M9V 4B4
Research Site
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Research Site
Pointe-Claire, Quebec, Canada, H9R 3J1
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01849497     History of Changes
Other Study ID Numbers: 20120348 
Study First Received: April 1, 2013
Results First Received: September 11, 2015
Last Updated: September 11, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Amgen:
LDL-C, triglycerides, high cholesterol

Additional relevant MeSH terms:
Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 08, 2016