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
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| ClinicalTrials.gov Identifier: NCT01576484 |
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Recruitment Status :
Completed
First Posted : April 12, 2012
Last Update Posted : February 9, 2018
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Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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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
Genetics Home Reference related topics:
Hypercholesterolemia
| 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 :
- 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 :
- 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.
- 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.
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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 |
Criteria
Inclusion Criteria:
Key Inclusion Criteria
- Prior participation in and the successful completion of the R727-CL-1003 study.
- Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study
- A negative urine pregnancy at the screening/baseline visit for women of childbearing potential
Exclusion Criteria:
Key Exclusion Criteria
- 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
- Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient
- 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 ClinicalTrials.gov identifier (NCT number): NCT01576484
Locations
| 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
Sanofi
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov 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:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |