Long-term Safety and Tolerability of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01507831
First received: January 6, 2012
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
Primary Objective:
To evaluate the long-term safety and tolerability of SAR236553 (REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT)
Secondary Objectives:
- To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Other: placebo Drug: SAR236553 (REGN727) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 20 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percent change in calculated low density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
- Percent change in calculated 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: | 2100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 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 modifying 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 modifying 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 88 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: Either A or B below and who are not adequately controlled with their lipid-modifying therapy: A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents. Exclusion criteria: -Age < 18 years -LDL-C <70 mg/dL (< 1.81 mmol/L) -Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) 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: NCT01507831
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| United States, Alabama | |
| Investigational Site Number 840159 | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
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| Mesa, Arizona, United States, 85206 | |
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| Sierra Vista, Arizona, United States, 85635 | |
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| Tempe, Arizona, United States, 85282 | |
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| Tempe, Arizona, United States, 85282 | |
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| Beverly Hills, California, United States, 90210 | |
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| Encinitas, California, United States, 92024 | |
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| Fresno, California, United States, 93720 | |
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| Long Beach, California, United States, 90806 | |
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| Los Angeles, California, United States, 90067 | |
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| Pasadena, California, United States, 91105 | |
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| Roseville, California, United States, 95661 | |
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| Golden, Colorado, United States, 80401 | |
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| Bridgeport, Connecticut, United States, 06610 | |
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| Guilford, Connecticut, United States, 06437 | |
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| Hartford, Connecticut, United States, 06102 | |
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| Beach, Florida, United States, 32168 | |
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| Brandon, Florida, United States, 33511 | |
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| Clearwater, Florida, United States, 33765 | |
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| Clearwater, Florida, United States, 33756 | |
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| Daytona Beach, Florida, United States, 32117 | |
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| Daytona Beach, Florida, United States, 32117 | |
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| Hollywood, Florida, United States, 33021 | |
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| Jacksonville, Florida, United States, 32216 | |
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| United States, Georgia | |
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| Columbus, Georgia, United States, 31904 | |
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| Henderson, Nevada, United States, 78014 | |
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| Bronx, New York, United States, 10468 | |
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| Bronxville, New York, United States, 10708 | |
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| Brooklyn, New York, United States, 11215 | |
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| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
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| Asheville, North Carolina, United States, 28803 | |
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| Charlotte, North Carolina, United States, 28211 | |
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| Charlotte, North Carolina, United States, 28262 | |
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| Greensboro, North Carolina, United States, 27408 | |
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| Raleigh, North Carolina, United States | |
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| Cincinnati, Ohio, United States, 45236 | |
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| Dayton, Ohio, United States, 45406 | |
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| Marion, Ohio, United States, 43302 | |
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| Mentor, Ohio, United States, 44060 | |
| United States, Oklahoma | |
| Investigational Site Number 840005 | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Investigational Site Number 840170 | |
| Beaver, Pennsylvania, United States, 15009 | |
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| Duncansville, Pennsylvania, United States, 16635 | |
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| Harleysville, Pennsylvania, United States, 19438 | |
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| Jersey Shore, Pennsylvania, United States, 17740 | |
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| Newport, Pennsylvania, United States, 17074 | |
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| Scranton, Pennsylvania, United States, 18503 | |
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| Wyomissing, Pennsylvania, United States, 19610 | |
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| Pawleys Island, South Carolina, United States, 29585 | |
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| Simpsonville, South Carolina, United States, 29681 | |
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| Knoxville, Tennessee, United States, 37917-4524 | |
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| Brownsville, Texas, United States, 78521 | |
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| Dallas, Texas, United States, 75231 | |
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| Dallas, Texas, United States | |
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| Dallas, Texas, United States, 75235 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Fort Worth, Texas, United States, 76117 | |
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| Houston, Texas, United States, 77024 | |
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| Houston, Texas, United States, 77074 | |
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| Plano, Texas, United States, 75023 | |
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| San Antonio, Texas, United States, 78258 | |
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| Sugar Land, Texas, United States, 77479 | |
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| Tyler, Texas, United States, 75701 | |
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| Investigational Site Number 840031 | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
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| Salem, Virginia, United States, 24153 | |
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| Virginia Beach, Virginia, United States, 23454 | |
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| Investigational Site Number 840120 | |
| Spokane, Washington, United States, 99204 | |
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| Tacoma, Washington, United States | |
| United States, Wisconsin | |
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| Madison, Wisconsin, United States, 53719 | |
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| Milwaukee, Wisconsin, United States, 53209 | |
| Argentina | |
| Investigational Site Number 032006 | |
| Buenos Aires, Argentina, 1425 | |
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| Caba, Argentina, 1440 | |
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| Capital Federal, Argentina, 1119 | |
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| Coronel Suarez, Argentina, B7540GHD | |
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| Ramos Mejia, Argentina, 1704 | |
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| Resistencia, Argentina, 3500 | |
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| Zarate, Argentina, 2800 | |
| Belgium | |
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| Antwerpen, Belgium, 2020 | |
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| Drongen, Belgium, 9031 | |
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| Genk, Belgium, 3600 | |
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| Massemen, Belgium, 9230 | |
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| Natoye, Belgium, 5360 | |
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| Plovdiv, Bulgaria, 4002 | |
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| Sofia, Bulgaria, 1606 | |
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| Varna, Bulgaria, 9000 | |
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| Burlington, Canada, L7M 4Y1 | |
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| Coquitlam, Canada, V3K 3P4 | |
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| Czech Republic | |
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| Ceske Budejovice, Czech Republic, 307 01 | |
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| Praha 2, Czech Republic, 128 08 | |
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| Aarhus, Denmark, 8200 | |
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| Bandol, France, 83150 | |
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| Paris Cedex 13, France, 75651 | |
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| Cinisello Balsamo, Italy, 20092 | |
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| Milano, Italy, 20138 | |
| Investigational Site Number 380007 | |
| Napoli, Italy, 80131 | |
| Investigational Site Number 380001 | |
| Palermo, Italy, 90127 | |
| Investigational Site Number 380005 | |
| Pozzilli, Italy, 86077 | |
| Investigational Site Number 380004 | |
| Rome, Italy, 00133 | |
| Investigational Site Number 380008 | |
| Vittorio Veneto, Italy, 31029 | |
| Investigational Site Number 380010 | |
| Zingonia-Osio Sotto, Italy | |
| Mexico | |
| Investigational Site Number 484010 | |
| Df, Mexico, 03300 | |
| Investigational Site Number 484004 | |
| Mexico, Mexico, 06090 | |
| Investigational Site Number 484008 | |
| Not Provided, Mexico | |
| Investigational Site Number 484001 | |
| San Luis Potosi, Mexico, 78200 | |
| Investigational Site Number 484002 | |
| Tijuana, Mexico, 22500 | |
| Investigational Site Number 484003 | |
| Xalapa, Mexico, 91020 | |
| Netherlands | |
| Investigational Site Number 528001 | |
| Amsterdam, Netherlands, 1105 AZ | |
| Investigational Site Number 528013 | |
| Amsterdam, Netherlands, 1091 AC | |
| Investigational Site Number 528004 | |
| Breda, Netherlands, 4811 SW | |
| Investigational Site Number 528005 | |
| Eindhoven, Netherlands, 5616GB | |
| Investigational Site Number 528007 | |
| Groningen, Netherlands, 9711 SG | |
| Investigational Site Number 528011 | |
| Hoogeveen, Netherlands, 7909 AA | |
| Investigational Site Number 528002 | |
| Hoorn, Netherlands, 1625 HV | |
| Investigational Site Number 528008 | |
| Leiderdorp, Netherlands, 2352 RA | |
| Investigational Site Number 528009 | |
| Rotterdam, Netherlands, 3021 HC | |
| Investigational Site Number 528006 | |
| Velp, Netherlands, 6883 ES | |
| Investigational Site Number 528012 | |
| Venlo, Netherlands, 5912 BL | |
| Investigational Site Number 528010 | |
| Zoetermeer, Netherlands, 2724 EK | |
| Norway | |
| Investigational Site Number 578005 | |
| Elverum, Norway, 2402 | |
| Investigational Site Number 578001 | |
| Hamar, Norway, 2317 | |
| Investigational Site Number 578002 | |
| Oslo, Norway | |
| Investigational Site Number 578004 | |
| Skedsmokorset, Norway, 2020 | |
| Investigational Site Number 578003 | |
| Stavanger, Norway, 4005 | |
| Poland | |
| Investigational Site Number 616006 | |
| Elblag, Poland, 82-300 | |
| Investigational Site Number 616008 | |
| Gdynia, Poland, 81-384 | |
| Investigational Site Number 616003 | |
| Gdynia, Poland, 81423 | |
| Investigational Site Number 616001 | |
| Gniewkowo, Poland, 88-140 | |
| Investigational Site Number 616010 | |
| Katowice, Poland, 40-748 | |
| Investigational Site Number 616014 | |
| Krakow, Poland, 31-501 | |
| Investigational Site Number 616004 | |
| Piotrkow Trybunalski, Poland, 97-300 | |
| Investigational Site Number 616015 | |
| Poland, Poland, 42-500 | |
| Investigational Site Number 616013 | |
| Pulawy, Poland, 24-100 | |
| Investigational Site Number 616009 | |
| Warszawa, Poland, 02-777 | |
| Investigational Site Number 616007 | |
| Wroclaw, Poland, 50-088 | |
| Portugal | |
| Investigational Site Number 620006 | |
| Funchal / Madeira, Portugal, 9050 | |
| Investigational Site Number 620002 | |
| Lisboa, Portugal, 1649-035 | |
| Investigational Site Number 620003 | |
| Lisboa, Portugal, 1649-035 | |
| Investigational Site Number 620005 | |
| Porto, Portugal, 4200-319 | |
| Romania | |
| Investigational Site Number 642005 | |
| Baia Mare, Romania, 430031 | |
| Investigational Site Number 642002 | |
| Brasov, Romania, 500283 | |
| Investigational Site Number 642006 | |
| Pitesti, Romania, 110084 | |
| Investigational Site Number 642004 | |
| Targu Mures, Romania, 540099 | |
| Russian Federation | |
| Investigational Site Number 643005 | |
| Barnaul, Russian Federation, 656038 | |
| Investigational Site Number 643012 | |
| Moscow, Russian Federation, 119415 | |
| Investigational Site Number 643008 | |
| Moscow, Russian Federation, 125284 | |
| Investigational Site Number 643002 | |
| Moscow, Russian Federation, 129327 | |
| Investigational Site Number 643014 | |
| Perm, Russian Federation, 614097 | |
| Investigational Site Number 643006 | |
| St Petersburg, Russian Federation, 196084 | |
| Investigational Site Number 643007 | |
| St Petersburg, Russian Federation, 196084 | |
| Investigational Site Number 643009 | |
| St.Petersburg, Russian Federation, 196084 | |
| Investigational Site Number 643004 | |
| Yaroslavl, Russian Federation, 150002 | |
| South Africa | |
| Investigational Site Number 710008 | |
| Meyerspark, South Africa, 0184 | |
| Investigational Site Number 710011 | |
| Middelburg, South Africa, 1055 | |
| Investigational Site Number 710006 | |
| Parktown, South Africa, 2193 | |
| Investigational Site Number 710004 | |
| Pretoria, South Africa, 0002 | |
| Investigational Site Number 710001 | |
| Pretoria, South Africa, 0084 | |
| Investigational Site Number 710002 | |
| Pretoria, South Africa, 181 | |
| Investigational Site Number 710009 | |
| Roodepoort, South Africa, 1724 | |
| Investigational Site Number 710003 | |
| Somerset West, South Africa, 7130 | |
| Investigational Site Number 710005 | |
| Witbank, South Africa | |
| Investigational Site Number 710007 | |
| Worcester, South Africa, 6850 | |
| Spain | |
| Investigational Site Number 724006 | |
| Córdoba, Spain, 14004 | |
| Investigational Site Number 724003 | |
| Granada, Spain, 18012 | |
| Investigational Site Number 724002 | |
| Madrid, Spain, 28040 | |
| Investigational Site Number 724007 | |
| Málaga, Spain, 29010 | |
| Investigational Site Number 724008 | |
| Quart De Poblet, Spain, 46930 | |
| Investigational Site Number 724005 | |
| Reus, Spain, 43201 | |
| Investigational Site Number 724001 | |
| Sabadell, Spain, 08208 | |
| Investigational Site Number 724004 | |
| Sevilla, Spain, 41013 | |
| Sweden | |
| Investigational Site Number 752002 | |
| Rättvik, Sweden, 79530 | |
| Investigational Site Number 752006 | |
| Stockholm, Sweden, 111 35 | |
| Investigational Site Number 752003 | |
| Stockholm, Sweden, 111 57 | |
| Investigational Site Number 752004 | |
| Stockholm, Sweden, 14186 | |
| Investigational Site Number 752001 | |
| Örebro, Sweden, 70146 | |
| Ukraine | |
| Investigational Site Number 804012 | |
| Chernivtsi, Ukraine, 58013 | |
| Investigational Site Number 804003 | |
| Dnipropetrovsk, Ukraine, 49006 | |
| Investigational Site Number 804002 | |
| Donetsk, Ukraine, 83114 | |
| Investigational Site Number 804014 | |
| Kharkiv, Ukraine, 61002 | |
| Investigational Site Number 804016 | |
| Kiev, Ukraine, 02091 | |
| Investigational Site Number 804013 | |
| Kyiv, Ukraine | |
| Investigational Site Number 804005 | |
| Zhytomyr, Ukraine, 10002 | |
| United Kingdom | |
| Investigational Site Number 826004 | |
| Addlestone, United Kingdom, KT15 2BH | |
| Investigational Site Number 826009 | |
| Birmingham, United Kingdom, B15 2SQ | |
| Investigational Site Number 826016 | |
| Birmingham, United Kingdom, B18 7QH | |
| Investigational Site Number 826012 | |
| Cardiff, United Kingdom, CF14 5GJ | |
| Investigational Site Number 826024 | |
| Chichester, United Kingdom, PO19 4SE | |
| Investigational Site Number 826003 | |
| Irvine, United Kingdom, KA12 0AY | |
| Investigational Site Number 826008 | |
| Liverpool, United Kingdom, L22 0LG | |
| Investigational Site Number 826025 | |
| Manchester, United Kingdom, M13 9WL | |
| Investigational Site Number 826007 | |
| Manchester, United Kingdom, M15 6SX | |
| Investigational Site Number 826018 | |
| Northampton, United Kingdom, NN1 5BD | |
| Investigational Site Number 826001 | |
| Northwood, United Kingdom, HA6 2RN | |
| Investigational Site Number 826019 | |
| Penzance, United Kingdom, TR19 7HH | |
| Investigational Site Number 826011 | |
| Reading, United Kingdom, RG2 7AG | |
| Investigational Site Number 826013 | |
| Romford, United Kingdom, RM7 0AG | |
| Investigational Site Number 826006 | |
| Wigan, United Kingdom, WN1 1XX | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01507831 History of Changes |
| Other Study ID Numbers: | LTS11717, 2011-002806-59, U1111-1121-3928 |
| Study First Received: | January 6, 2012 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013