Trial record 15 of 62 for:    regeneron AND LDL-

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576484
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: REGN727 (SAR236553) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Open Label Drug: REGN727 (SAR236553)
REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

Primary Outcome Measures :
  1. Incidence of AEs from baseline to end of study [ Time Frame: Baseline (Day 1) to week 218 (End of study) ]
    Incidence of AEs from baseline (Day 1) to week 218 (end of study)

Secondary Outcome Measures :
  1. Percent change in LDL-C: Baseline to weeks 12, 24, 52 and 218 [ Time Frame: Baseline (Day 1) to weeks 12, 24, 52 and 218 (End of study) ]
    Percent change in calculated serum LDL-C (Low-density lipoprotein cholesterol) from baseline (average of values calculated at Screening Visit and Baseline [Day 1] visits) in the current study to weeks 12, 24, 52 and 218.

  2. Changes in other lipids and other lipoproteins [ Time Frame: Baseline (Day 1) and week 218 (End of study) ]
    To evaluate the effect of REGN727 on other lipid parameters.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576484

United States, California
Mission Viejo, California, United States
Newport Beach, California, United States
Thousand Oaks, California, United States
United States, Florida
Miami, Florida, United States
Port Orange, Florida, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maine
Auburn, Maine, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
Houston, Texas, United States
Canada, Quebec
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01576484     History of Changes
Other Study ID Numbers: R727-CL-1032
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases