Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01812707
First received: March 14, 2013
Last updated: August 21, 2015
Last verified: August 2015
Results First Received: August 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Alirocumab
Drug: Placebo (for alirocumab)
Drug: Atorvastatin

  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 4 centers in Japan. Overall, 162 participants were screened between March 2013 and August 2013, 62 of whom were run-in/screen failures, mainly due to exclusion criteria met.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1 ratio after confirmation of selection criteria. 100 participants were randomized.

Reporting Groups
  Description
Placebo Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 75 mg Q2W Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.

Participant Flow:   Overall Study
    Placebo     Alirocumab 50 mg Q2W     Alirocumab 75 mg Q2W     Alirocumab 150 mg Q2W  
STARTED     25     25     25     25  
Treated     25     25     25     25  
COMPLETED     23     25     25     23  
NOT COMPLETED     2     0     0     2  
Adverse Event                 0                 0                 0                 2  
Poor compliance to protocol                 1                 0                 0                 0  
Consent withdrawn by participant                 1                 0                 0                 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.
Randomized population.

Reporting Groups
  Description
Placebo Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 75 mg Q2W Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Total Total of all reporting groups

Baseline Measures
    Placebo     Alirocumab 50 mg Q2W     Alirocumab 75 mg Q2W     Alirocumab 150 mg Q2W     Total  
Number of Participants  
[units: participants]
  25     25     25     25     100  
Age  
[units: years]
Mean (Standard Deviation)
  58.6  (9.2)     57.8  (12.3)     56.3  (12.0)     58.2  (8.8)     57.7  (10.6)  
Gender  
[units: participants]
         
Female     11     16     12     16     55  
Male     14     9     13     9     45  
Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L  
[units: mmol/L]
Mean (Standard Deviation)
  3.13  (0.55)     3.16  (0.43)     3.13  (0.43)     3.12  (0.42)     3.14  (0.45)  
LDL-C in mg/dL  
[units: mg/dL]
Mean (Standard Deviation)
  121.0  (21.1)     122.2  (16.6)     120.9  (16.7)     120.5  (16.2)     121.2  (17.5)  



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

2.  Secondary:   Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis   [ Time Frame: Baseline to Week 12 (LOCF) ]

3.  Secondary:   Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis   [ Time Frame: Baseline to Week 12 (LOCF) ]

4.  Secondary:   Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis   [ Time Frame: Week 12 (LOCF) ]

5.  Secondary:   Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis   [ Time Frame: Baseline to Week 12 (LOCF) ]

6.  Secondary:   Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis   [ Time Frame: Baseline to Week 12 (LOCF) ]

7.  Secondary:   Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis   [ Time Frame: From Baseline to Week 12 (LOCF) ]


  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: Trial Transparency Team
Organization: Sanofi
e-mail: Contact ­-US@sanofi.com


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01812707     History of Changes
Other Study ID Numbers: DFI12361
U1111-1134-4749 ( Other Identifier: UTN )
Study First Received: March 14, 2013
Results First Received: August 21, 2015
Last Updated: August 21, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency