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Trial record 1 of 1 for:    01813422
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GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

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ClinicalTrials.gov Identifier: NCT01813422
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Biological: Evolocumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 163 centers in 30 countries in Europe, North America, Asia Pacific, and Latin America. The first participant was enrolled on 18 April 2013 and the last participant enrolled on 12 January 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met all entry criteria were randomized 1:1 to receive evolocumab 420 mg once monthly (QM) subcutaneous (SC) or placebo QM SC for 76 weeks. Randomization was stratified by region.

Reporting Groups
  Description
Placebo Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Evolocumab Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.

Participant Flow:   Overall Study
    Placebo   Evolocumab
STARTED   486   484 
Received Treatment   484   484 
COMPLETED   466   468 
NOT COMPLETED   20   16 
Withdrawal by Subject                14                8 
Death                2                3 
Sponsor Decision                2                1 
Lost to Follow-up                2                4 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Evolocumab Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Evolocumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 486   484   970 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (8.8)   59.8  (9.6)   59.8  (9.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      135  27.8%      135  27.9%      270  27.8% 
Male      351  72.2%      349  72.1%      700  72.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      24   4.9%      34   7.0%      58   6.0% 
Not Hispanic or Latino      462  95.1%      450  93.0%      912  94.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   2   0   2 
Asian   17   14   31 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   5   4   9 
White   453   456   909 
Multiple   6   7   13 
Other   3   2   5 
Stratification Factor: Geographical Region 
[Units: Participants]
     
North America   88   86   174 
Europe   332   332   664 
Latin America   16   15   31 
Asia Pacific   50   51   101 


  Outcome Measures

1.  Primary:   Change From Baseline in Percent Atheroma Volume at Week 78   [ Time Frame: Baseline and week 78 ]

2.  Secondary:   Change From Baseline in Total Atheroma Volume at Week 78   [ Time Frame: Baseline and week 78 ]

3.  Secondary:   Percentage of Participants With Regression in Percent Atheroma Volume   [ Time Frame: Baseline and week 78 ]

4.  Secondary:   Percentage of Participants With Regression in Total Atheroma Volume   [ Time Frame: Baseline and week 78 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01813422     History of Changes
Other Study ID Numbers: 20120153
2012-004208-37 ( EudraCT Number )
First Submitted: March 15, 2013
First Posted: March 19, 2013
Results First Submitted: December 4, 2017
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018