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.
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
12
sites
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