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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:
ClinicalTrials.gov Identifier:
NCT01849497
First Posted: May 8, 2013
Last Update Posted: October 9, 2015
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.
Information provided by (Responsible Party):
Amgen
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


  Show 26 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01849497     History of Changes
Other Study ID Numbers: 20120348
First Submitted: April 1, 2013
First Posted: May 8, 2013
Results First Submitted: September 11, 2015
Results First Posted: October 9, 2015
Last Update Posted: October 9, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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