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Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 (GAUSS-3)

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ClinicalTrials.gov Identifier: NCT01984424
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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

  Participant Flow

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

A total of 511 participants were enrolled (492 in Part A and 19 directly in Part B) at 53 centers in the United States of America, Europe, Australia, New Zealand, Canada, and South Africa from December 2013 to November 2014.

Results are reported for participants randomized in Part B. Part C was ongoing at the time of this analysis.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 492 patients were randomized in part A; of those, 202 completed both periods and experienced muscle-related side effects during the atorvastatin period and not during the placebo period. Of the 202, 199 enrolled in Part B. Nineteen additional patients bypassed part A, as permitted by protocol, and advanced directly into part B.

Reporting Groups
  Description
Ezetimibe Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
Evolocumab Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.

Participant Flow:   Overall Study
    Ezetimibe   Evolocumab
STARTED   73   145 
COMPLETED   70   138 
NOT COMPLETED   3   7 
Withdrawal by Subject                3                5 
Sponsor Decision                0                1 
Lost to Follow-up                0                1 



  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
Ezetimibe Participants received 10 mg ezetimibe orally once a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
Evolocumab Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Ezetimibe   Evolocumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 73   145   218 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.5  (9.4)   59.0  (11.1)   58.8  (10.5) 
Age, Customized 
[Units: Participants]
Count of Participants
     
< 65 years      52  71.2%      92  63.4%      144  66.1% 
≥ 65 years      21  28.8%      53  36.6%      74  33.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      39  53.4%      67  46.2%      106  48.6% 
Male      34  46.6%      78  53.8%      112  51.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      2   1.4%      2   0.9% 
Not Hispanic or Latino      73 100.0%      143  98.6%      216  99.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.4%      2   1.4%      3   1.4% 
Black or African American      3   4.1%      3   2.1%      6   2.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
White      69  94.5%      138  95.2%      207  95.0% 
Other      0   0.0%      2   1.4%      2   0.9% 
Stratification Factor: Screening Low-density Lipoprotein Cholesterol (LDL-C) 
[Units: Participants]
Count of Participants
     
< 180 mg/dL      21  28.8%      40  27.6%      61  28.0% 
≥ 180 mg/dL      52  71.2%      105  72.4%      157  72.0% 
LDL-C Concentation 
[Units: mg/dL]
Mean (Standard Deviation)
 221.9  (70.2)   218.8  (73.1)   219.9  (72.0) 
Total Cholesterol Concentration 
[Units: mg/dL]
Mean (Standard Deviation)
 308.0  (73.8)   306.5  (75.4)   307.0  (74.7) 
High-density Lipoprotein Cholesterol (HDL-C) 
[Units: mg/dL]
Mean (Standard Deviation)
 50.2  (15.5)   49.7  (15.4)   49.8  (15.4) 
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration 
[Units: mg/dL]
Mean (Standard Deviation)
 35.7  (14.3)   37.1  (15.6)   36.7  (15.1) 
Non-high-density Lipoprotein Cholesterol (non-HDL-C) Concentration 
[Units: mg/dL]
Mean (Standard Deviation)
 257.8  (76.3)   256.9  (73.8)   257.2  (74.5) 
Apolipoprotein B Concentration 
[Units: mg/dL]
Mean (Standard Deviation)
 155.0  (42.4)   158.3  (41.5)   157.2  (41.7) 
Total Cholesterol/HDL-C Ratio 
[Units: Ratio]
Mean (Standard Deviation)
 6.709  (2.746)   6.668  (2.349)   6.682  (2.483) 
Apolipoprotein B/Apolipoprotein A1 Ratio 
[Units: Ratio]
Mean (Standard Deviation)
 1.063  (0.416)   1.063  (0.340)   1.063  (0.366) 
Triglyceride Concentration 
[Units: mg/dL]
Median (Inter-Quartile Range)
 162.5 
 (127.0 to 231.0) 
 176.0 
 (128.0 to 233.5) 
 171.3 
 (127.0 to 233.0) 
Lipoprotein(a) Concentration 
[Units: nmol/L]
Median (Inter-Quartile Range)
 38.0 
 (18.0 to 164.0) 
 29.0 
 (12.5 to 152.5) 
 31.0 
 (15.0 to 156.0) 


  Outcome Measures

1.  Primary:   Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

2.  Primary:   Percent Change From Baseline in LDL-C at Week 24   [ Time Frame: Baseline and week 24 ]

3.  Secondary:   Change From Baseline in LDL-C at the Mean of Weeks 22 and 24   [ Time Frame: Baselie and weeks 22 and 24 ]

4.  Secondary:   Change From Baseline in LDL-C at Week 24   [ Time Frame: Baseline and week 24 ]

5.  Secondary:   Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL   [ Time Frame: Weeks 22 and 24 ]

6.  Secondary:   Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL   [ Time Frame: Week 24 ]

7.  Secondary:   Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

8.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 24   [ Time Frame: Baseline and week 24 ]

9.  Secondary:   Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

10.  Secondary:   Percent Change From Baseline in Non-HDL-C at Week 24   [ Time Frame: Baseline and week 24 ]

11.  Secondary:   Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

12.  Secondary:   Percent Change From Baseline in Apolipoprotein B at Week 24   [ Time Frame: Baseline and week 24 ]

13.  Secondary:   Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

14.  Secondary:   Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24   [ Time Frame: Baseline and week 24 ]

15.  Secondary:   Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and Weeks 22 and 24 ]

16.  Secondary:   Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24   [ Time Frame: Baseline and week 24 ]

17.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and Weeks 22 and 24 ]

18.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at Week 24   [ Time Frame: Baseline and week 24 ]

19.  Secondary:   Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

20.  Secondary:   Percent Change From Baseline in Triglycerides at Week 24   [ Time Frame: Baseline and week 24 ]

21.  Secondary:   Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24   [ Time Frame: Baseline and weeks 22 and 24 ]

22.  Secondary:   Percent Change From Baseline in HDL-C at Week 24   [ Time Frame: Baseline and week 24 ]

23.  Secondary:   Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24   [ Time Frame: Baseline and weeks 22 and 24 ]

24.  Secondary:   Percent Change From Baseline in VLDL-C at Week 24   [ Time Frame: Baseline and week 24 ]


  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: NCT01984424     History of Changes
Other Study ID Numbers: 20120332
2013-000935-29 ( EudraCT Number )
First Submitted: November 8, 2013
First Posted: November 14, 2013
Results First Submitted: December 4, 2017
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018