Status:
COMPLETED
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To evaluate the effect of aliroc...
Detailed Description
The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 we...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- \- Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit.
- OR
- \- Participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.
- Exclusion criteria:
- LDL-C \<100 mg/dL (\<2.59 mmol/L)
- at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR
- at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening
- Participants with type 1 diabetes
- Participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01812707
Start Date
March 1 2013
End Date
January 1 2014
Last Update
October 4 2016
Active Locations (4)
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1
Investigational Site Number 392002
Koganeishi, Japan
2
Investigational Site Number 392001
Shinjuku-Ku, Japan
3
Investigational Site Number 392003
Suita-Shi, Japan
4
Investigational Site Number 392004
Suita-Shi, Japan