A Randomized, Multi-center Clinical Study in Subjects With Hypercholesterolemia or Mixed Dyslipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01879319
First received: June 13, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This is a multi-center, randomized study in subjects with high cholesterol to assess subjects' ability to administer a full dose of evolocumab (AMG 145) via subcutaneous injection.


Condition Intervention Phase
Primary Hypercholesterolemia or Mixed Dyslipidemia
Device: evolocumab (AMG 145)
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 Subject With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer Evolocumab (AMG 145)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Combination of subject reported outcomes across two attempted full-dose administrations of evolocumab (AMG 145) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The administration outcomes of each planned administration at weeks 4 and 8 will be combined for each subject. The proportion of subjects with each combination of outcomes at weeks 4 and 8 will be estimated by treatment group.


Secondary Outcome Measures:
  • Percent change from baseline in LDL-C at weeks 10 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    mean percent change from baseline in low density lipoprotein-cholesterol


Enrollment: 164
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: evolocumab (AMG 145) Device 1 Device: evolocumab (AMG 145)
Delivers evolocumab (AMG 145) via subcutaneous injection
Active Comparator: evolocumab (AMG 145) Device 2 Device: evolocumab (AMG 145)
Delivers evolocumab (AMG 145) via subcutaneous injection

  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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879319

  Show 27 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01879319     History of Changes
Other Study ID Numbers: 20120356
Study First Received: June 13, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on April 15, 2014