Dan Gipe, MD- World Health Organization - Patients With HeFH Hypercholesterolemia Main Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: Last refreshed on: Main ID: Date of registration: Primary sponsor: Public title:
ClinicalTrials.gov 17 October 2012 NCT01266876 23/12/2010 Regeneron Pharmaceuticals Study of the Safety and Efficacy of REGN727(SAR236553) in Patients With HeFH Hypercholesterolemia A Randomized, Double-Blind, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of REGN727 in Patients With Heterozygous Familial Hypercholesterolemia
Scientific title: Date of first January 2011 enrolment: Target 77 sample size: Recruitment Completed status: http://clinicaltrials.gov/show/NCT01266876 URL: Study type: Interventional Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Study Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment design: Countries of recruitment Canada
Netherlands
United States
Contacts Name: Address: Telephone: Email: Affiliation:
Dan Gipe, MD
Regeneron Pharmaceuticals
Key inclusion & exclusion criteria Inclusion Criteria: 1. Must meet the WHO criteria for heFH 2. Patients must be on a stable statin dose, with or without ezetimibe, for at least 6 weeks before screening
3. Serum LDL-C levels = 100 mg/dL at screening 4. Willing to follow the NCEP ATPIII TLC diet, or an equivalent diet plan, starting at screening and continuing until the last study visit 5. A negative urine/serum pregnancy test at each screening visit and start of the study, for women of childbearing potential Key Exclusion Criteria: 1. Patients with homozygous FH (clinically or by previous genotyping) 2. Use of a medication (other than a statin or EZE) to alter serum lipids within 42 days (6 weeks) before screening including, but not limited to: - Fibrates - Niacin (>500 mg/day) - Omega-3 fatty acids (>1000 mg/day of DHA/EPA) - Bile acid resins 3. Use of nutraceuticals or OTC medications that may alter lipid levels that are not stable for at least 6 weeks before screening and are not planned to remain constant throughout the study. Examples include: - Omega-3 fatty acids (=1000 mg/day of DHA/EPA) - Niacin (=500 mg/day) - Plant stanols, such as found in Benecol, flax seed oil, psyllium - Red yeast rice 4. Disorders known to influence lipid levels, such as nephrotic syndrome, significant liver disease, Cushing's disease, untreated hypothyroidism (patients on stable thyroid replacement for at least 12 weeks before the full screening visit, who are metabolically euthyroid by thyroid-stimulating hormone (TSH) testing are allowed) 5. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before the full screening visit) 6. Fasting serum TG >350 mg/dL screening 7. LDL apheresis within 12 months before screening
Age minimum: 18 Years Age maximum: 75 Years
Gender: Both Health Condition(s) or Problem(s) studied Hypercholesterolemia Intervention(s) Biological: REGN727 (SAR236553) Other: Placebo Primary Outcome(s) Percent change of low-density lipoprotein cholesterol (LDL-C) from baseline to week 12 [Time Frame: 12 weeks] Secondary Outcome(s) Immunogenicity of repeated SC doses of REGN727 throughout the course of the study [Time Frame: 12 weeks] Percent change in LDL-C from baseline to each visit [Time Frame: 12 weeks] Pharmacokinetic (PK) profile of multiple doses of REGN727. [Time Frame: 12 weeks] Safety and tolerability of multiple doses of REGN727 [Time Frame: 12 weeks] Secondary ID(s) R727-CL-1003 Source(s) of Monetary Support Please refer to primary and secondary sponsors Secondary Sponsor(s) Sanofi-Aventis Regeneron Pharmaceuticals Dan Gipe, MD Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record. Copyright - World Health Organization - Version 3.1 - Version history