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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01849497
First received: April 1, 2013
Last updated: May 30, 2014
Last verified: May 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
Mixed Dyslipidemia
Biological: 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 Subjects 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: 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.


Secondary Outcome Measures:
  • 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


Enrollment: 149
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: evolocumab (AMG 145) Device 1 Biological: evolocumab (AMG 145)
Delivers evolocumab (AMG 145) via subcutaneous injection
Active Comparator: evolocumab (AMG 145) Device 2 Biological: 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
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

  Show 26 Study Locations
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
Last Updated: May 30, 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 September 18, 2014