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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:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01849497
First received: April 1, 2013
Last updated: September 11, 2015
Last verified: September 2015
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Interventions: Biological: Evolocumab Pre-filled Syringe
Biological: Evolocumab AI/pen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks.

The first patient enrolled on 18 April 2013 and last patient enrolled on 05 August 2013.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified on the basis of screening LDL-C concentration (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.

Reporting Groups
  Description
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.

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.

Participant Flow:   Overall Study
    Evolocumab PFS     Evolocumab AI/Pen  
STARTED     75     74  
Received Treatment     75     74  
COMPLETED     74     70  
NOT COMPLETED     1     4  
Withdrawal by Subject                 1                 2  
Sponsor Decision                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (all randomized participants who received at least 1 dose of study drug).

Reporting Groups
  Description
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).
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).
Total Total of all reporting groups

Baseline Measures
    Evolocumab PFS     Evolocumab AI/Pen     Total  
Number of Participants  
[units: participants]
  75     74     149  
Age  
[units: years]
Mean (Standard Deviation)
  61.2  (11.1)     60.6  (9.6)     60.9  (10.3)  
Gender  
[units: participants]
     
Female     36     26     62  
Male     39     48     87  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     7     9  
Black or African American     11     7     18  
Native Hawaiian or Other Pacific Islander     0     1     1  
White     62     58     120  
Missing     0     1     1  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic or Latino     9     6     15  
Not Hispanic or Latino     66     68     134  
Stratification Factor: LDL-C Level  
[units: participants]
     
< 130 mg/dL     56     56     112  
≥ 130 mg/dL     19     18     37  
LDL-C Concentration  
[units: mg/dL]
Mean (Standard Deviation)
  116.9  (25.0)     118.1  (28.7)     117.5  (26.8)  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4   [ Time Frame: Week 2 and Week 4 ]

2.  Secondary:   Percent Change From Baseline in LDL-C at Week 6   [ Time Frame: Baseline and Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



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