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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

April 1, 2013
May 30, 2014
March 2013
November 2013   (final data collection date for primary outcome measure)
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.
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: 6 Weeks ] [ Designated as safety issue: No ]
Mean percent change from baseline in low density lipoprotein-cholesterol
Same as current
Not Provided
Not Provided
 
A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia
A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer Evolocumab (AMG 145)

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.

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 (AMG 145)
Delivers evolocumab (AMG 145) via subcutaneous injection
  • Active Comparator: evolocumab (AMG 145) Device 1
    Intervention: Biological: evolocumab (AMG 145)
  • Active Comparator: evolocumab (AMG 145) Device 2
    Intervention: Biological: evolocumab (AMG 145)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
November 2013
November 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:
  • 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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01849497
20120348
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2014

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