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Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01266876
First received: December 23, 2010
Last updated: August 20, 2015
Last verified: August 2015
History of Changes
Results First Received: August 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Alirocumab
Drug: Placebo

  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
The study was conducted at 16 centers in the United States of America and Canada. Overall, 118 participants were screened between January 2011 and June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified by concomitant use of ezetimibe (Yes/No). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1 ratio after confirmation of selection criteria. 77 participants were randomized.

Reporting Groups
  Description
Placebo Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg Q4W Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg Q4W Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg Q4W Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg Q2W Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Participant Flow:   Overall Study
    Placebo     Alirocumab 150 mg Q4W     Alirocumab 200 mg Q4W     Alirocumab 300 mg Q4W     Alirocumab 150 mg Q2W  
STARTED     15     15     16     15     16  
COMPLETED     15     15     16     14     16  
NOT COMPLETED     0     0     0     1     0  
Adverse Event                 0                 0                 0                 1                 0  



  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 Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg Q4W Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg Q4W Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg Q4W Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg Q2W Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Alirocumab 150 mg Q4W     Alirocumab 200 mg Q4W     Alirocumab 300 mg Q4W     Alirocumab 150 mg Q2W     Total  
Number of Participants  
[units: participants]
 		  15     15     16     15     16     77  
Age  
[units: years]
Mean (Standard Deviation) 		  51.9  (9.6)     51.3  (7.7)     52.9  (11.2)     54.3  (9.6)     56.3  (10.2)     53.4  (9.7)  
Gender  
[units: participants]
 		           
Female     6     6     7     8     3     30  
Male     9     9     9     7     13     47  
Low Density Lipoprotein Cholesterol (LDL-C) in mg/dL [1]
[units: mg/dL]
Mean (Standard Deviation) 		  150.8  (34.0)     166.7  (50.1)     169.8  (57.0)     139.6  (24.7)     147.2  (32.6)     154.9  (42.1)  
[1] Calculated LDL-C from Friedewald formula.



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 1

2.  Secondary:   Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis   [ Time Frame: Week 12 (LOCF) ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis   [ Time Frame: Week 12 (LOCF) ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
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6.  Secondary:   Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 7

8.  Secondary:   Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 8

9.  Secondary:   Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
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10.  Secondary:   Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 10

11.  Secondary:   Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 ]
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12.  Secondary:   Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 12

13.  Secondary:   Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 13

14.  Secondary:   Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 ]
  Show Outcome Measure 14

15.  Secondary:   Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 15

16.  Secondary:   Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 16

17.  Secondary:   Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 ]
  Show Outcome Measure 17

18.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 18

19.  Secondary:   Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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  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: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc
e-mail: clinicaltrials@regeneron.com


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


Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01266876     History of Changes
Other Study ID Numbers: R727-CL-1003
Study First Received: December 23, 2010
Results First Received: August 20, 2015
Last Updated: August 20, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada