GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)
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| ClinicalTrials.gov Identifier: NCT01813422 |
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Recruitment Status :
Completed
First Posted : March 19, 2013
Results First Posted : January 4, 2018
Last Update Posted : February 20, 2019
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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| 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 |
| Enrollment | 970 |
Participant Flow
| Recruitment Details | 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 | 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. |
| Arm/Group Title | Placebo | Evolocumab |
|---|---|---|
 Arm/Group Description |
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. | Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. |
| Period Title: Overall Study | ||
| Started | 486 | 484 |
| Received Treatment | 484 | 484 |
| Completed | 466 | 468 |
| Not Completed | 20 | 16 |
| Reason Not Completed | ||
| Withdrawal by Subject | 14 | 8 |
| Death | 2 | 3 |
| Sponsor Decision | 2 | 1 |
| Lost to Follow-up | 2 | 4 |
Baseline Characteristics
| Arm/Group Title | Placebo | Evolocumab | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. | Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 486 | 484 | 970 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 486 participants | 484 participants | 970 participants | |
| 59.8 (8.8) | 59.8 (9.6) | 59.8 (9.2) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 486 participants | 484 participants | 970 participants | |
| Female |
135 27.8%
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135 27.9%
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270 27.8%
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| Male |
351 72.2%
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349 72.1%
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700 72.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 486 participants | 484 participants | 970 participants | |
| Hispanic or Latino |
24 4.9%
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34 7.0%
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58 6.0%
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| Not Hispanic or Latino |
462 95.1%
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450 93.0%
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912 94.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 486 participants | 484 participants | 970 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 | |
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Stratification Factor: Geographical Region
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 486 participants | 484 participants | 970 participants |
| North America | 88 | 86 | 174 | |
| Europe | 332 | 332 | 664 | |
| Latin America | 16 | 15 | 31 | |
| Asia Pacific | 50 | 51 | 101 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Amgen Inc. |
| Phone: | 866-572-6436 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01813422 |
| 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: | February 20, 2019 |