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Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II)

This study is currently recruiting participants.
Verified June 2013 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644188
First received: July 16, 2012
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 (REGN727) as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

  • To evaluate the effect of SAR236553 (REGN727) in comparison with ezetimibe on LDL-C at other time points.
  • To evaluate the effect of SAR236553 (REGN727) on other lipid parameters.
  • To evaluate the safety and tolerability of SAR236553 (REGN727).

Condition Intervention Phase
Hypercholesterolemia
 Drug: SAR236553 (REGN727)
Drug: matching placebo SAR236553 (REGN727)
Drug: Ezetimibe
Drug: matching placebo for Ezetimibe
 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, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
Drug Information available for: Ezetimibe
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 12 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR236553 (REGN727) / Ezetimibe placebo
Injection through subcutaneous (SC) administration. Ezetimibe placebo is administered orally.
 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

Drug: matching placebo for Ezetimibe
Pharmaceutical form:capsules Route of administration: oral
Active Comparator: SAR236553 (REGN727) Placebo / Ezetimibe
Injection through subcutaneous (SC) administration. Ezetimibe is administered orally.
 Drug: matching placebo SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Drug: Ezetimibe
Pharmaceutical form:encapsulated tablets Route of administration: oral

Detailed Description:

The maximum study duration will be 114 weeks per patient, including a 2 week screening period, 104 week randomized treatment period and 8 week follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater.
  • Patients without established CHD or CHD risk equivalents.
  • LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
  • LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
  • 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: NCT01644188

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840956 Recruiting
Birmingham, Alabama, United States, 35213
Investigational Site Number 840980 Recruiting
Brimingham, Alabama, United States, 35205
United States, Arizona
Investigational Site Number 840918 Recruiting
Phoenix, Arizona, United States, 85032
Investigational Site Number 840925 Recruiting
Tucson, Arizona, United States
United States, California
Investigational Site Number 840959 Recruiting
Anaheim, California, United States, 92801
Investigational Site Number 840301 Recruiting
Beverly Hills, California, United States, 90211
Investigational Site Number 840933 Recruiting
Chino, California, United States, 91710
Investigational Site Number 840942 Recruiting
Fountain Valley, California, United States, 92708
Investigational Site Number 840979 Recruiting
Los Angeles, California, United States, 90057
Investigational Site Number 840952 Recruiting
Palm Springs, California, United States, 92262
Investigational Site Number 840991 Recruiting
Roseville, California, United States, 95661
Investigational Site Number 840921 Recruiting
Vista, California, United States, 92083
Investigational Site Number 840930 Recruiting
Westlake Village, California, United States, 91361
United States, Colorado
Investigational Site Number 840916 Recruiting
Wheatridge, Colorado, United States, 80033
United States, Florida
Investigational Site Number 840962 Recruiting
Boynton Beach, Florida, United States
Investigational Site Number 840987 Recruiting
Bradenton, Florida, United States, 34203
Investigational Site Number 840302 Recruiting
Clearwater, Florida, United States, 33756
Investigational Site Number 840935 Recruiting
Jacksonville, Florida, United States, 32223
Investigational Site Number 840903 Recruiting
Miami, Florida, United States, 33126
Investigational Site Number 840920 Recruiting
Miami, Florida, United States
Investigational Site Number 840943 Recruiting
Ocala, Florida, United States, 34471
Investigational Site Number 840981 Recruiting
Oveido, Florida, United States, 32765
Investigational Site Number 840961 Recruiting
Port Orange, Florida, United States, 32127
Investigational Site Number 840303 Recruiting
Sarasota, Florida, United States, 34239
Investigational Site Number 840988 Recruiting
Tampa, Florida, United States, 33606
United States, Idaho
Investigational Site Number 840995 Recruiting
Meridian, Idaho, United States, 83646
United States, Indiana
Investigational Site Number 840902 Recruiting
Evansville, Indiana, United States, 47714
United States, Kansas
Investigational Site Number 840960 Recruiting
Topeka, Kansas, United States, 66614
United States, Maryland
Investigational Site Number 840940 Recruiting
Oxon Hill, Maryland, United States, 20745
United States, Massachusetts
Investigational Site Number 840966 Recruiting
Fall River, Massachusetts, United States, 02720
Investigational Site Number Recruiting
Fall River, Massachusetts, United States, 02720
United States, Missouri
Investigational Site Number 840917 Recruiting
Kansas City, Missouri, United States, 64115
Investigational Site Number 840998 Recruiting
St. Louis, Missouri, United States, 63131
United States, Montana
Investigational Site Number 840946 Recruiting
Butte, Montana, United States, 59701
United States, Nebraska
Investigational Site Number 840914 Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Mexico
Investigational Site Number 840949 Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Investigational Site Number 840993 Recruiting
Bronxville, New York, United States, 10708
Investigational Site Number 840974 Recruiting
New Windsor, New York, United States, 12553
Investigational Site Number 840986 Recruiting
New York, New York, United States
United States, North Carolina
Investigational Site Number 840955 Recruiting
Greenville, North Carolina, United States, 27834
Investigational Site Number 840976 Recruiting
Smithfield, North Carolina, United States, 27577
Investigational Site Number 840938 Recruiting
Winston-Salem, North Carolina, United States
Investigational Site Number 840985 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Investigational Site Number 840963 Recruiting
Cincinatti, Ohio, United States
Investigational Site Number 840970 Recruiting
Lyndhust, Ohio, United States, 44124
Investigational Site Number 840997 Recruiting
Marion, Ohio, United States, 43302
Investigational Site Number 840906 Recruiting
Mt. Gilead, Ohio, United States, 43338
Investigational Site Number 840964 Recruiting
Perrysburg, Ohio, United States, 43554
United States, South Carolina
Investigational Site Number 840913 Recruiting
Charleston, South Carolina, United States, 29412
Investigational Site Number 840912 Recruiting
Greer, South Carolina, United States, 29651
Investigational Site Number 840992 Recruiting
Summerville, South Carolina, United States, 29485
United States, Tennessee
Investigational Site Number 840932 Completed
Bristol, Tennessee, United States, 37620
Investigational Site Number 840944 Completed
Nashville, Tennessee, United States, 37205
United States, Texas
Investigational Site Number 840994 Recruiting
Fort Worth, Texas, United States, 76104
Investigational Site Number 840939 Recruiting
Houston, Texas, United States, 77074
Investigational Site Number 840973 Recruiting
Houston, Texas, United States
Investigational Site Number 840945 Recruiting
Sugar Land, Texas, United States
Investigational Site Number 840971 Recruiting
Tomball, Texas, United States, 77375
United States, Utah
Investigational Site Number 840982 Recruiting
Orem, Utah, United States
United States, Virginia
Investigational Site Number 840931 Recruiting
Norfolk, Virginia, United States, 23502
Investigational Site Number 840984 Recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Investigational Site Number 840928 Recruiting
Renton, Washington, United States, 98055
Investigational Site Number 840990 Recruiting
Spokane, Washington, United States, 99204
Canada
Investigational Site Number 124902 Active, not recruiting
Brampton, Canada, L6T 3J1
Investigational Site Number 124914 Recruiting
Mirabel, Canada, J7J 2K8
Investigational Site Number 124903 Recruiting
Montreal, Canada, H1T 2M4
Investigational Site Number 124918 Active, not recruiting
Toronto, Canada, M9V 4B4
Investigational Site Number 124910 Recruiting
Winnipeg, Canada, R2H 0R8
Denmark
Investigational Site Number 208913 Recruiting
Esbjerg, Denmark, 6700
Investigational Site Number 208914 Recruiting
Glostrup, Denmark, 2600
Investigational Site Number 208905 Recruiting
Hellerup, Denmark, 2900
Investigational Site Number 208911 Recruiting
Herlev, Denmark, 2730
Investigational Site Number 208907 Recruiting
Hvidovre, Denmark, 2650
Investigational Site Number 208901 Recruiting
København S, Denmark, 2300
Investigational Site Number 208906 Recruiting
Køge, Denmark, 4600
Investigational Site Number 208908 Recruiting
Roskilde, Denmark, 4000
Investigational Site Number 208903 Recruiting
Silkeborg, Denmark, 8600
France
Investigational Site Number 250906 Recruiting
Dijon, France, 21000
Investigational Site Number 250907 Recruiting
Montpellier Cedex 5, France, 34295
Investigational Site Number 250903 Recruiting
Nantes Cedex 01, France, 44093
Investigational Site Number 250905 Recruiting
Nimes, France, 30029
Hungary
Investigational Site Number 348903 Recruiting
Budapest, Hungary, 1134
Investigational Site Number 348901 Recruiting
Budapest, Hungary, 1134
Investigational Site Number 348908 Recruiting
Budapest, Hungary, 1036
Investigational Site Number 348905 Recruiting
Debrecen, Hungary, 4032
Investigational Site Number 348906 Recruiting
Szekesfehervar, Hungary, 8000
Israel
Investigational Site Number 376908 Active, not recruiting
Holon, Israel, 58100
Investigational Site Number 376905 Recruiting
Jerusalem, Israel, 91120
Investigational Site Number 376903 Active, not recruiting
Kfar Saba, Israel, 44281
Investigational Site Number 376906 Active, not recruiting
Ofakim, Israel, 80300
Investigational Site Number 376902 Completed
Petach Tikva, Israel
Investigational Site Number 376904 Active, not recruiting
Rehovot, Israel, 76100
Investigational Site Number 376907 Active, not recruiting
Safed, Israel, 13100
Investigational Site Number 376901 Active, not recruiting
Tel Aviv, Israel, 64239
Korea, Republic of
Investigational Site Number 410908 Recruiting
Anyang, Korea, Republic of, 431-070
Investigational Site Number 410920 Recruiting
Busan, Korea, Republic of, 602-715
Investigational Site Number 410926 Recruiting
Daegu, Korea, Republic of, 700-712
Investigational Site Number 410923 Recruiting
Gwangju, Korea, Republic of, 501-757
Investigational Site Number 410918 Recruiting
Incheon, Korea, Republic of, 400-711
Investigational Site Number 410922 Recruiting
Seoul, Korea, Republic of, 120-752
Investigational Site Number 410909 Recruiting
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410901 Recruiting
Seoul, Korea, Republic of, 137-701
Investigational Site Number 410924 Recruiting
Seoul, Korea, Republic of, 156-707
Investigational Site Number 410925 Recruiting
Seoul, Korea, Republic of, 152-703
Investigational Site Number 410905 Recruiting
Seoul, Korea, Republic of, 135-720
Investigational Site Number 410914 Recruiting
Seoul, Korea, Republic of, 138-878
Investigational Site Number 410921 Recruiting
Seoul, Korea, Republic of, 135-710
Investigational Site Number 410915 Recruiting
Suwon, Korea, Republic of, 443-721
Investigational Site Number 410913 Recruiting
Uijeongbu, Korea, Republic of, 480-717
Investigational Site Number 410927 Recruiting
Wonju, Korea, Republic of, 220-701
Russian Federation
Investigational Site Number 643906 Active, not recruiting
Barnaul, Russian Federation, 656055
Investigational Site Number 643903 Active, not recruiting
Kemerovo, Russian Federation, 650002
Investigational Site Number 643924 Active, not recruiting
Moscow, Russian Federation, 119048
Investigational Site Number 643928 Active, not recruiting
Moscow, Russian Federation, 111539
Investigational Site Number 643908 Active, not recruiting
Moscow, Russian Federation, 121552
Investigational Site Number 643927 Active, not recruiting
Moscow, Russian Federation, 111539
Investigational Site Number 643904 Active, not recruiting
Moscow, Russian Federation, 129090
Investigational Site Number 643932 Active, not recruiting
Moscow, Russian Federation, 121374
Investigational Site Number 643923 Recruiting
Moscow, Russian Federation, 117292
Investigational Site Number 643931 Active, not recruiting
Moscow, Russian Federation, 115404
Investigational Site Number 643911 Active, not recruiting
Orenburg, Russian Federation, 450000
Investigational Site Number 643921 Active, not recruiting
Ryazan, Russian Federation, 390026
Investigational Site Number 643925 Active, not recruiting
Saint-Petersburg, Russian Federation, 197110
Investigational Site Number 643922 Active, not recruiting
Saint-Petersburg, Russian Federation, 198205
Investigational Site Number 643929 Recruiting
Saratov, Russian Federation, 410028
Investigational Site Number 643914 Active, not recruiting
St-Petersburg, Russian Federation, 199106
South Africa
Investigational Site Number 710917 Active, not recruiting
Alberton, South Africa, 1450
Investigational Site Number 710914 Recruiting
Bloemfontein, South Africa, 9301
Investigational Site Number 710909 Active, not recruiting
Bloemfontein, South Africa, 9301
Investigational Site Number 710904 Active, not recruiting
Cape Town, South Africa, 7708
Investigational Site Number 710918 Active, not recruiting
Middelburg, South Africa, 1055
Investigational Site Number 710905 Active, not recruiting
Parow, South Africa, 7500
Investigational Site Number 710913 Active, not recruiting
Pretoria, South Africa, 0002
Investigational Site Number 710915 Active, not recruiting
Somerset West, South Africa, 7130
Ukraine
Investigational Site Number 804905 Recruiting
Kiev, Ukraine, 02091
Investigational Site Number 804901 Recruiting
Kyiv, Ukraine, 04050
Investigational Site Number 804903 Recruiting
Kyiv, Ukraine, 04050
Investigational Site Number 804902 Active, not recruiting
Uzhhorod, Ukraine, 88009
Investigational Site Number 804911 Recruiting
Zaporozhye, Ukraine, 69118
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01644188     History of Changes
Other Study ID Numbers: EFC11569, U1111-1121-4315
Study First Received: July 16, 2012
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013