Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 (SAR236553) in Patients With Hypercholesterolemia

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	2/11/2018
Start Date:	March 2012
End Date:	December 2016

A Phase 2, Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 Administered by Subcutaneous Injection in Patients With Heterozygous Familial Hypercholesterolemia

This is a phase 2, open-label extension study to assess the long-term safety and efficacy of
REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously
participating in the R727-CL-1003 study.

Inclusion Criteria:

Key Inclusion Criteria

1. Prior participation in and the successful completion of the R727-CL-1003 study.

2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to
entry into the study

3. A negative urine pregnancy at the screening/baseline visit for women of childbearing
potential

Exclusion Criteria:

Key Exclusion Criteria

1. Reported a drug-related SAE or drug-related clinical or laboratory AE in the
R727-CL-1003 study that resulted in early termination or withdrawal

2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the
investigator or patient

3. LDL apheresis within 12 months before the screening/baseline visit

We found this trial at

sites

Clinical Trial Facility in Port Orange Florida

Port Orange, Florida

1134

from

Port Orange, FL