Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644188
First received: July 16, 2012
Last updated: June 23, 2016
Last verified: June 2016
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Purpose
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.
Secondary Objectives:
- To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
- To evaluate the effect of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: Alirocumab Drug: Placebo (for alirocumab) Drug: Ezetimibe Drug: Placebo (for ezetimibe) Drug: Lipid Modifying Therapy (LMT) |
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:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
Secondary Outcome Measures:
- Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline up to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Total-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
- Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.
- Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
- Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
- Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Other Outcome Measures:
- Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
- Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis [ Time Frame: From Baseline to Week 104 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.
- Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis [ Time Frame: From Baseline to Week 104 ] [ Designated as safety issue: No ]Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
| Enrollment: | 720 |
| Study Start Date: | August 2012 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alirocumab 75 /up to 150 mg Q2W
Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
|
Drug: Alirocumab
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Other Names:
Drug: Placebo (for ezetimibe)
One capsule once daily orally at approximately the same time of the day with or without food.
Drug: Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
|
|
Active Comparator: Ezetimibe 10 mg
Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.
|
Drug: Placebo (for alirocumab)
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Drug: Ezetimibe
One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
Drug: Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
|
Detailed Description:
The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were 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 was greater
- Participants without established CHD or CHD risk equivalents
- LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
- LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease
- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644188
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01644188
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Locations
| United States, Alabama | |
| Investigational Site Number 840980 | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Investigational Site Number 840918 | |
| Phoenix, Arizona, United States, 85032 | |
| Investigational Site Number 840925 | |
| Tucson, Arizona, United States | |
| United States, California | |
| Investigational Site Number 840959 | |
| Anaheim, California, United States, 92801 | |
| Investigational Site Number 840301 | |
| Beverly Hills, California, United States, 90211 | |
| Investigational Site Number 840933 | |
| Chino, California, United States, 91710 | |
| Investigational Site Number 840991 | |
| Lincoln, California, United States, 95648 | |
| Investigational Site Number 840979 | |
| Los Angeles, California, United States, 90057 | |
| Investigational Site Number 840952 | |
| Palm Springs, California, United States, 92262 | |
| Investigational Site Number 840930 | |
| Thousand Oaks, California, United States, 91360 | |
| Investigational Site Number 840921 | |
| Vista, California, United States, 92083 | |
| United States, Florida | |
| Investigational Site Number 840962 | |
| Boynton Beach, Florida, United States, 33472 | |
| Investigational Site Number 840987 | |
| Bradenton, Florida, United States, 34203 | |
| Investigational Site Number 840302 | |
| Clearwater, Florida, United States, 33756 | |
| Investigational Site Number 840935 | |
| Jacksonville, Florida, United States, 32223 | |
| Investigational Site Number 840903 | |
| Miami, Florida, United States, 33126 | |
| Investigational Site Number 840920 | |
| Miami, Florida, United States | |
| Investigational Site Number 840943 | |
| Ocala, Florida, United States, 34471 | |
| Investigational Site Number 840981 | |
| Oveido, Florida, United States, 32765 | |
| Investigational Site Number 840961 | |
| Port Orange, Florida, United States, 32127 | |
| Investigational Site Number 840303 | |
| Sarasota, Florida, United States, 34239 | |
| Investigational Site Number 840986 | |
| St. Petersburg, Florida, United States | |
| Investigational Site Number 840988 | |
| St. Petersburg, Florida, United States | |
| United States, Idaho | |
| Investigational Site Number 840995 | |
| Meridian, Idaho, United States, 83646 | |
| United States, Indiana | |
| Investigational Site Number 840902 | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kansas | |
| Investigational Site Number 840960 | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| Investigational Site Number 840940 | |
| Oxon Hill, Maryland, United States, 20745 | |
| United States, Massachusetts | |
| Investigational Site Number 840966 | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Missouri | |
| Investigational Site Number 840917 | |
| Kansas City, Missouri, United States, 64114 | |
| Investigational Site Number 840998 | |
| St. Louis, Missouri, United States, 63131 | |
| United States, Montana | |
| Investigational Site Number 840946 | |
| Butte, Montana, United States, 59701 | |
| United States, Nebraska | |
| Investigational Site Number 840914 | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, New Mexico | |
| Investigational Site Number 840949 | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Investigational Site Number 840974 | |
| New Windsor, New York, United States, 12553 | |
| United States, North Carolina | |
| Investigational Site Number 840955 | |
| Greenville, North Carolina, United States, 27834 | |
| Investigational Site Number 840938 | |
| Lexington, North Carolina, United States, 27292 | |
| Investigational Site Number 840976 | |
| Smithfield, North Carolina, United States, 27577 | |
| Investigational Site Number 840985 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Investigational Site Number 840963 | |
| Cincinnati, Ohio, United States, 45219 | |
| Investigational Site Number 840970 | |
| Lyndhust, Ohio, United States, 44124 | |
| Investigational Site Number 840906 | |
| Marion, Ohio, United States, 43302 | |
| Investigational Site Number 840997 | |
| Marion, Ohio, United States, 43302 | |
| Investigational Site Number 840964 | |
| Perrysburg, Ohio, United States, 43551 | |
| United States, South Carolina | |
| Investigational Site Number 840913 | |
| Charleston, South Carolina, United States, 29412 | |
| Investigational Site Number 840912 | |
| Greer, South Carolina, United States, 29651 | |
| Investigational Site Number 840992 | |
| Summerville, South Carolina, United States, 29485 | |
| United States, Tennessee | |
| Investigational Site Number 840932 | |
| Bristol, Tennessee, United States, 37620 | |
| Investigational Site Number 840944 | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Investigational Site Number 840994 | |
| Fort Worth, Texas, United States, 76104 | |
| Investigational Site Number 840973 | |
| Houston, Texas, United States, 77070 | |
| Investigational Site Number 840939 | |
| Houston, Texas, United States, 77074 | |
| Investigational Site Number 840945 | |
| Sugar Land, Texas, United States, 77479 | |
| Investigational Site Number 840971 | |
| Tomball, Texas, United States, 77375 | |
| United States, Utah | |
| Investigational Site Number 840982 | |
| Orem, Utah, United States, 84058 | |
| United States, Virginia | |
| Investigational Site Number 840931 | |
| Norfolk, Virginia, United States, 23502 | |
| Investigational Site Number 840984 | |
| Richmond, Virginia, United States, 23227 | |
| United States, Washington | |
| Investigational Site Number 840928 | |
| Renton, Washington, United States, 98055 | |
| Investigational Site Number 840990 | |
| Spokane, Washington, United States, 99204 | |
| Canada | |
| Investigational Site Number 124902 | |
| Brampton, Canada, L6T 3J1 | |
| Investigational Site Number 124914 | |
| Mirabel, Canada, J7J 2K8 | |
| Investigational Site Number 124903 | |
| Montreal, Canada, H1T 3Y7 | |
| Investigational Site Number 124918 | |
| Toronto, Canada, M9V 4B4 | |
| Denmark | |
| Investigational Site Number 208913 | |
| Esbjerg, Denmark, 6700 | |
| Investigational Site Number 208914 | |
| Glostrup, Denmark, 2600 | |
| Investigational Site Number 208905 | |
| Hellerup, Denmark, 2900 | |
| Investigational Site Number 208911 | |
| Herlev, Denmark, 2730 | |
| Investigational Site Number 208907 | |
| Hvidovre, Denmark, 2650 | |
| Investigational Site Number 208901 | |
| København S, Denmark, 2300 | |
| Investigational Site Number 208906 | |
| Køge, Denmark, 4600 | |
| Investigational Site Number 208908 | |
| Roskilde, Denmark, 4000 | |
| Investigational Site Number 208903 | |
| Silkeborg, Denmark, 8600 | |
| France | |
| Investigational Site Number 250906 | |
| Dijon, France, 21079 | |
| Investigational Site Number 250907 | |
| Montpellier Cedex 5, France, 34295 | |
| Investigational Site Number 250903 | |
| Nantes, France, 44093 | |
| Investigational Site Number 250905 | |
| Nimes, France, 30900 | |
| Hungary | |
| Investigational Site Number 348908 | |
| Budapest, Hungary, 1036 | |
| Investigational Site Number 348901 | |
| Budapest, Hungary, 1134 | |
| Investigational Site Number 348903 | |
| Budapest, Hungary, 1134 | |
| Investigational Site Number 348905 | |
| Debrecen, Hungary, 4032 | |
| Investigational Site Number 348906 | |
| Szekesfehervar, Hungary, 8000 | |
| Israel | |
| Investigational Site Number 376908 | |
| Holon, Israel, 58100 | |
| Investigational Site Number 376903 | |
| Kfar Saba, Israel, 44281 | |
| Investigational Site Number 376906 | |
| Ofakim, Israel, 80300 | |
| Investigational Site Number 376902 | |
| Petach Tikva, Israel | |
| Investigational Site Number 376904 | |
| Rehovot, Israel, 76100 | |
| Investigational Site Number 376907 | |
| Safed, Israel, 13100 | |
| Investigational Site Number 376901 | |
| Tel Aviv, Israel, 64239 | |
| Korea, Republic of | |
| Investigational Site Number 410908 | |
| Anyang-Si, Korea, Republic of, 431-070 | |
| Investigational Site Number 410920 | |
| Busan, Korea, Republic of, 602-715 | |
| Investigational Site Number 410926 | |
| Daegu, Korea, Republic of, 700-712 | |
| Investigational Site Number 410923 | |
| Gwangju, Korea, Republic of, 501-757 | |
| Investigational Site Number 410909 | |
| Seoul, Korea, Republic of, 110-744 | |
| Investigational Site Number 410922 | |
| Seoul, Korea, Republic of, 120-752 | |
| Investigational Site Number 410921 | |
| Seoul, Korea, Republic of, 135-710 | |
| Investigational Site Number 410905 | |
| Seoul, Korea, Republic of, 135-720 | |
| Investigational Site Number 410901 | |
| Seoul, Korea, Republic of, 137-701 | |
| Investigational Site Number 410914 | |
| Seoul, Korea, Republic of, 138-736 | |
| Investigational Site Number 410924 | |
| Seoul, Korea, Republic of, 156-707 | |
| Investigational Site Number 410915 | |
| Suwon, Korea, Republic of, 443-721 | |
| Investigational Site Number 410913 | |
| Uijeongbu, Korea, Republic of, 480-717 | |
| Investigational Site Number 410927 | |
| Wonju, Korea, Republic of, 220-701 | |
| Russian Federation | |
| Investigational Site Number 643906 | |
| Barnaul, Russian Federation, 656055 | |
| Investigational Site Number 643903 | |
| Kemerovo, Russian Federation, 650002 | |
| Investigational Site Number 643927 | |
| Moscow, Russian Federation, 111539 | |
| Investigational Site Number 643928 | |
| Moscow, Russian Federation, 111539 | |
| Investigational Site Number 643931 | |
| Moscow, Russian Federation, 115404 | |
| Investigational Site Number 643924 | |
| Moscow, Russian Federation, 119048 | |
| Investigational Site Number 643932 | |
| Moscow, Russian Federation, 121374 | |
| Investigational Site Number 643908 | |
| Moscow, Russian Federation, 121552 | |
| Investigational Site Number 643904 | |
| Moscow, Russian Federation, 129090 | |
| Investigational Site Number 643911 | |
| Orenburg, Russian Federation, 450000 | |
| Investigational Site Number 643921 | |
| Ryazan, Russian Federation, 390026 | |
| Investigational Site Number 643925 | |
| Saint-Petersburg, Russian Federation, 197110 | |
| Investigational Site Number 643922 | |
| Saint-Petersburg, Russian Federation, 198205 | |
| Investigational Site Number 643929 | |
| Saratov, Russian Federation, 410028 | |
| Investigational Site Number 643914 | |
| St-Petersburg, Russian Federation, 199106 | |
| South Africa | |
| Investigational Site Number 710917 | |
| Alberton, South Africa, 1450 | |
| Investigational Site Number 710909 | |
| Bloemfontein, South Africa, 9301 | |
| Investigational Site Number 710914 | |
| Bloemfontein, South Africa, 9301 | |
| Investigational Site Number 710905 | |
| Cape Town, South Africa, 7500 | |
| Investigational Site Number 710904 | |
| Cape Town, South Africa, 7925 | |
| Investigational Site Number 710918 | |
| Middelburg, South Africa, 1055 | |
| Investigational Site Number 710913 | |
| Pretoria, South Africa, 0002 | |
| Investigational Site Number 710915 | |
| Somerset West, South Africa, 7130 | |
| Ukraine | |
| Investigational Site Number 804905 | |
| Kiev, Ukraine, 02091 | |
| Investigational Site Number 804902 | |
| Uzhhorod, Ukraine, 88009 | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01644188 History of Changes |
| Other Study ID Numbers: | EFC11569 U1111-1121-4315 2011-004130-34 |
| Study First Received: | July 16, 2012 |
| Results First Received: | August 20, 2015 |
| Last Updated: | June 23, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Antibodies, Monoclonal |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016