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Dan Gipe, MD- World Health Organization - Patients With HeFH Hypercholesterolemia

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					Dan Gipe, MD- World Health Organization - Patients With HeFH Hypercholesterolemia
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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:         ClinicalTrials.gov
Last
refreshed         17 October 2012
on:
Main ID:          NCT01266876
Date of
                  23/12/2010
registration:
Primary
                  Regeneron Pharmaceuticals
sponsor:
                  Study of the Safety and Efficacy of REGN727(SAR236553) in Patients With
Public title:
                  HeFH Hypercholesterolemia
Scientific        A Randomized, Double-Blind, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of
title:            REGN727 in Patients With Heterozygous Familial Hypercholesterolemia
Date of first
              January 2011
enrolment:
Target
              77
sample size:
Recruitment
              Completed
status:
URL:          http://clinicaltrials.gov/show/NCT01266876
Study type: Interventional
Study         Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model:
design:       Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Countries of recruitment
Canada                                              Netherlands                                              United States

Contacts
Name:                                                Dan Gipe, MD
Address:
Telephone:
Email:
Affiliation:                                       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

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