Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)
This study is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01623115
First received: June 15, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
Primary Objective: To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo Secondary Objectives: -To evaluate the effect of SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points -To evaluate the effects of SAR236553 (REGN727) on other lipid parameters -To evaluate the safety and tolerability of SAR236553 (REGN727)
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: SAR236553 (REGN727) Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent change in LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
- Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 471 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR236553 (REGN727)
Injection through subcutaneous (SC) administration. Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.
|
Drug: SAR236553 (REGN727)
SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:Solution for injection Route of administration: subcutaneous |
|
Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration. Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.
|
Other: placebo
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
|
Detailed Description:
The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy
Exclusion criteria:
- Age < 18 years or legal age of adulthood, whichever is greater -LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
- LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
- Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
- Known history of homozygous familial hypercholesterolemia
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623115
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Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
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| United States, California | |
| Investigational Site Number 840417 | Recruiting |
| Bell Gardens, California, United States, 90201 | |
| Investigational Site Number 840429 | Recruiting |
| Long Beach, California, United States, 90801 | |
| Investigational Site Number 840419 | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Investigational Site Number 840421 | Recruiting |
| Mission Viejo, California, United States, 92691 | |
| Investigational Site Number 840412 | Recruiting |
| Newport Beach, California, United States, 92660 | |
| Investigational Site Number 840428 | Recruiting |
| Newport Beach, California, United States | |
| Investigational Site Number 840461 | Recruiting |
| Northridge, California, United States, 91324 | |
| United States, District of Columbia | |
| Investigational Site Number 840452 | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Investigational Site Number 840456 | Recruiting |
| Miami, Florida, United States, 33165 | |
| Investigational Site Number 840418 | Recruiting |
| Ponte Vedra, Florida, United States, 32081 | |
| United States, Illinois | |
| Investigational Site Number 840455 | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| United States, Kansas | |
| Investigational Site Number 840415 | Recruiting |
| Kansas City, Kansas, United States, 66160-7321 | |
| United States, Maine | |
| Investigational Site Number 840425 | Recruiting |
| Auburn, Maine, United States, 04210 | |
| United States, Massachusetts | |
| Investigational Site Number 840411 | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Missouri | |
| Investigational Site Number 840409 | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Investigational Site Number 840407 | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| United States, New York | |
| Investigational Site Number 840408 | Recruiting |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Investigational Site Number 840401 | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Investigational Site Number 840410 | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Investigational Site Number 840430 | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| Investigational Site Number 840424 | Recruiting |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| Investigational Site Number 840404 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Investigational Site Number 840426 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Investigational Site Number 840406 | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Investigational Site Number 840460 | Recruiting |
| Dallas, Texas, United States, 75216 | |
| United States, Utah | |
| Investigational Site Number 840422 | Recruiting |
| Bountiful, Utah, United States, 84010 | |
| Austria | |
| Investigational Site Number 040403 | Recruiting |
| Graz, Austria, 8036 | |
| Investigational Site Number 040402 | Recruiting |
| Wien, Austria, 1130 | |
| Investigational Site Number 040405 | Recruiting |
| Wien, Austria | |
| Canada | |
| Investigational Site Number 124404 | Recruiting |
| Chicoutimi, Canada, G7H 5H6 | |
| Investigational Site Number 124401 | Recruiting |
| Montreal, Canada, H2W 1R7 | |
| Investigational Site Number 124403 | Recruiting |
| Quebec, Canada, G1V 4M6 | |
| Investigational Site Number 124406 | Recruiting |
| Sherbrooke, Canada, J1H 5N4 | |
| Investigational Site Number 124407 | Recruiting |
| Toronto, Canada, M5C 2T2 | |
| Czech Republic | |
| Investigational Site Number 203401 | Recruiting |
| Praha, Czech Republic, 140 00 | |
| Investigational Site Number 203403 | Recruiting |
| Praha, Czech Republic, 180 00 | |
| Investigational Site Number 203405 | Recruiting |
| Uherske Hradiste, Czech Republic | |
| Investigational Site Number 203402 | Recruiting |
| Zlin, Czech Republic, 760 00 | |
| Denmark | |
| Investigational Site Number 208401 | Recruiting |
| Copenhagen, Denmark | |
| Investigational Site Number 208403 | Recruiting |
| Esbjerg, Denmark, 6700 | |
| France | |
| Investigational Site Number 250403 | Recruiting |
| Dijon, France, 21000 | |
| Investigational Site Number 250401 | Recruiting |
| Paris Cedex 13, France, 75651 | |
| Investigational Site Number 250402 | Recruiting |
| Saint Herblain, France, 44093 | |
| Israel | |
| Investigational Site Number 376402 | Recruiting |
| Holon, Israel, 76100 | |
| Investigational Site Number 376405 | Recruiting |
| Jerusalem, Israel | |
| Investigational Site Number 376404 | Recruiting |
| Safed, Israel, 13100 | |
| Investigational Site Number 376401 | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Netherlands | |
| Investigational Site Number 528406 | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Investigational Site Number 528410 | Recruiting |
| Amsterdam, Netherlands | |
| Investigational Site Number 528408 | Recruiting |
| Den Helder, Netherlands, 1782 GZ | |
| Investigational Site Number 528402 | Recruiting |
| Groningen, Netherlands, 9728 NT | |
| Investigational Site Number 528411 | Recruiting |
| Leiden, Netherlands, 2333 ZA | |
| Investigational Site Number 528416 | Recruiting |
| Maastricht, Netherlands, 6229 HX | |
| Investigational Site Number 528409 | Recruiting |
| Nieuwegein, Netherlands, 3435 CM | |
| Investigational Site Number 528412 | Recruiting |
| Sliedrecht, Netherlands | |
| Norway | |
| Investigational Site Number 578401 | Recruiting |
| Bodø, Norway, 8092 | |
| Russian Federation | |
| Investigational Site Number 643402 | Recruiting |
| Arkhangelsk, Russian Federation, 163000 | |
| Investigational Site Number 643407 | Recruiting |
| Kazan, Russian Federation, 420012 | |
| Investigational Site Number 643409 | Recruiting |
| Moscow, Russian Federation, 111539 | |
| Investigational Site Number 643413 | Recruiting |
| Moscow, Russian Federation, 121552 | |
| Investigational Site Number 643401 | Recruiting |
| Moscow, Russian Federation, 129301 | |
| Investigational Site Number 643412 | Recruiting |
| Novisibirsk, Russian Federation | |
| Investigational Site Number 643408 | Recruiting |
| St-Petersburg, Russian Federation, 193079 | |
| Investigational Site Number 643404 | Recruiting |
| St-Petersburg, Russian Federation, 197341 | |
| Investigational Site Number 643406 | Recruiting |
| St-Petersburg, Russian Federation, 194291 | |
| Investigational Site Number 643410 | Recruiting |
| Yaroslavl, Russian Federation, 150062 | |
| South Africa | |
| Investigational Site Number 710405 | Recruiting |
| Bloemfontein, South Africa | |
| Investigational Site Number 710401 | Recruiting |
| Bloemfontein, South Africa | |
| Investigational Site Number 710406 | Recruiting |
| Cap Town, South Africa, 7530 | |
| Investigational Site Number 710402 | Recruiting |
| Cape Town, South Africa, 7708 | |
| Investigational Site Number 710407 | Recruiting |
| Parktown, South Africa, 2193 | |
| Investigational Site Number 710403 | Recruiting |
| Parow, South Africa, 7500 | |
| Investigational Site Number 710408 | Recruiting |
| Pretoria, South Africa | |
| Investigational Site Number 710404 | Recruiting |
| Rondebosch, South Africa | |
| Investigational Site Number 710409 | Recruiting |
| Somerset West, South Africa, 7130 | |
| Spain | |
| Investigational Site Number 724403 | Recruiting |
| A Coruna, Spain, 15006 | |
| Investigational Site Number 724408 | Recruiting |
| Barcelona, Spain, 08036 | |
| Investigational Site Number 724406 | Recruiting |
| Córdoba, Spain, 14004 | |
| Investigational Site Number 724407 | Recruiting |
| Hospitalet De Llobregat, Spain, 08907 | |
| Investigational Site Number 724409 | Recruiting |
| Madrid, Spain, 28029 | |
| Investigational Site Number 724401 | Recruiting |
| Madrid, Spain, 28040 | |
| Investigational Site Number 724405 | Recruiting |
| Madrid, Spain, 28040 | |
| Investigational Site Number 724404 | Recruiting |
| Reus, Spain, 43201 | |
| Investigational Site Number 724402 | Recruiting |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Investigational Site Number 752404 | Recruiting |
| Goteborg, Sweden, 41345 | |
| Investigational Site Number 752401 | Recruiting |
| Stockholm, Sweden, 111 35 | |
| United Kingdom | |
| Investigational Site Number 826402 | Recruiting |
| London, United Kingdom | |
| Investigational Site Number 826403 | Recruiting |
| London, United Kingdom | |
| Investigational Site Number 826409 | Recruiting |
| London, United Kingdom | |
| Investigational Site Number 826408 | Recruiting |
| London, United Kingdom | |
| Investigational Site Number 826405 | Recruiting |
| Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01623115 History of Changes |
| Other Study ID Numbers: | EFC12492, U1111-1121-4275 |
| Study First Received: | June 15, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
PCSK9 |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
ClinicalTrials.gov processed this record on May 21, 2013