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Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study (DESCARTES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01516879
First received: January 18, 2012
Last updated: August 28, 2015
Last verified: August 2015
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Biological: Evolocumab
Biological: Placebo
Drug: Atorvastatin
Drug: Ezetimibe
Other: Diet Only

  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
Adults with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 75 mg/dL and triglycerides ≤ 400 mg/dL were eligible. The first patient enrolled on 5 January 2012 and the last patient enrolled on 12 October 2012. All patients were counseled on the National Cholesterol Education Program Adult Treatment Panel III Therapeutic Lifestyle Changes diet.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were assigned to 1 of 4 background lipid-lowering regimens for a 4-12 week stabilization period: diet alone, diet and 10 mg atorvastatin daily, diet and 80 mg atorvastatin daily, or diet, 80 mg atorvastatin and 10 mg ezetimibe daily. Patients meeting criteria were randomized 2:1 to evolocumab or placebo, stratified by background therapy.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Evolocumab Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Participant Flow:   Overall Study
    Placebo   Evolocumab
STARTED   303   602 
Received Treatment   302   599 
COMPLETED   287   568 
NOT COMPLETED   16   34 
Withdrawal by Subject                9                11 
Death                0                2 
Lost to Follow-up                2                11 
Other                5                10 



  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.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Evolocumab Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Total Total of all reporting groups

Baseline Measures
   Placebo   Evolocumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 303   602   905 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (10.3)   55.9  (10.9)   56.1  (10.7) 
Gender 
[Units: Participants]
     
Female   162   312   474 
Male   141   290   431 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   0   3   3 
Asian   16   41   57 
Black or African American   23   53   76 
Native Hawaiian or Other Pacific Islander   0   1   1 
White   249   478   727 
Other   13   26   39 
Mixed Race   2   0   2 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic/Latino   17   33   50 
Not Hispanic/Latino   286   569   855 
Background Therapy 
[Units: Participants]
     
Diet Only   38   74   112 
Diet + Atorvastatin 10 mg   129   256   385 
Diet + Atorvastatin 80 mg   73   146   219 
Diet + Atorvastatin 80 mg + Ezetimibe 10 mg   63   126   189 
Low-density Lipoprotein Cholesterol (LDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 104.0  (21.6)   104.2  (22.1)   104.1  (22.0) 
[1] Cholesterol was measured by means of ultracentrifugation. Data are provided for the Full Analysis Set (all participants who were randomized and received at least 1 dose of study treatment).
Total Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 179.1  (27.2)   176.8  (27.5)   177.6  (27.4) 
[1] Data are provided for the Full Analysis Set
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 125.6  (26.9)   124.2  (25.6)   124.6  (26.1) 
[1] Data are provided for the Full Analysis Set
Apolipoprotein B Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 87.5  (16.3)   87.0  (16.3)   87.2  (16.3) 
[1] Data are provided for the Full Analysis Set
Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 3.603  (1.11)   3.597  (1.04)   3.599  (1.06) 
[1] Data are provided for the Full Analysis Set
Apolipoprotein B/Apolipoprotein A-1 Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 0.586  (0.170)   0.593  (0.170)   0.590  (1.70) 
[1] Data are provided for the Full Analysis Set
Lipoprotein(a) Concentration [1] 
[Units: nmol/L]
Mean (Standard Deviation)
 89.3  (108.6)   84.0  (98.5)   85.8  (102.0) 
[1] Data are provided for the Full Analysis Set
Triglycerides Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 127.8  (65.8)   119.8  (63.2)   122.5  (64.1) 
[1] Data are provided for the Full Analysis Set
High-density Lipoprotein Cholesterol (HDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 53.5  (16.1)   52.6  (15.5)   52.9  (15.7) 
[1] Data are providedfor the Full Analysis Set
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 21.5  (13.4)   20.0  (11.4)   20.5  (12.1) 
[1] Data are provided for the Full Analysis Set


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in LDL-C at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Change From Baseline in LDL-C at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Percentage of Participants With an LDL-C Response at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Percent Change From Baseline in LDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 52   [ Time Frame: Baseline and Week 52 ]

7.  Secondary:   Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52   [ Time Frame: Baseline and Week 52 ]

8.  Secondary:   Percent Change From Baseline in Apolipoprotein B at Week 52   [ Time Frame: Baseline and Week 52 ]

9.  Secondary:   Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52   [ Time Frame: Baseline and Week 52 ]

10.  Secondary:   Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at Week 52   [ Time Frame: Baseline and Week 52 ]

12.  Secondary:   Percent Change From Baseline in Triglycerides at Week 52   [ Time Frame: Baseline and Week 52 ]

13.  Secondary:   Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52   [ Time Frame: Baseline and Week 52 ]

14.  Secondary:   Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52   [ Time Frame: Baseline and Week 52 ]

15.  Secondary:   Percent Change From Week 12 to Week 52 in LDL-C   [ Time Frame: Week 12 and Week 52 ]


  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


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

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01516879     History of Changes
Other Study ID Numbers: 20110109
Study First Received: January 18, 2012
Results First Received: August 28, 2015
Last Updated: August 28, 2015
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
South Africa: Medicines Control Council
Hungary: National Institute of Pharmacy
Australia: Department of Health and Ageing Therapeutic Goods Administration