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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  
Number of Participants  
[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)  
Total Cholesterol [2]
[units: mg/dL]
Mean (Standard Deviation)
  179.1  (27.2)     176.8  (27.5)     177.6  (27.4)  
Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Concentration [2]
[units: mg/dL]
Mean (Standard Deviation)
  125.6  (26.9)     124.2  (25.6)     124.6  (26.1)  
Apolipoprotein B Concentration [2]
[units: mg/dL]
Mean (Standard Deviation)
  87.5  (16.3)     87.0  (16.3)     87.2  (16.3)  
Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio [2]
[units: ratio]
Mean (Standard Deviation)
  3.603  (1.11)     3.597  (1.04)     3.599  (1.06)  
Apolipoprotein B/Apolipoprotein A-1 Ratio [2]
[units: ratio]
Mean (Standard Deviation)
  0.586  (0.170)     0.593  (0.170)     0.590  (1.70)  
Lipoprotein(a) Concentration [2]
[units: nmol/L]
Mean (Standard Deviation)
  89.3  (108.6)     84.0  (98.5)     85.8  (102.0)  
Triglycerides Concentration [2]
[units: mg/dL]
Mean (Standard Deviation)
  127.8  (65.8)     119.8  (63.2)     122.5  (64.1)  
High-density Lipoprotein Cholesterol (HDL-C) Concentration [3]
[units: mg/dL]
Mean (Standard Deviation)
  53.5  (16.1)     52.6  (15.5)     52.9  (15.7)  
Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration [2]
[units: mg/dL]
Mean (Standard Deviation)
  21.5  (13.4)     20.0  (11.4)     20.5  (12.1)  
[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).
[2] Data are provided for the Full Analysis Set
[3] Data are providedfor the Full Analysis Set



  Outcome Measures
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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
No text entered.


  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