- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926782
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
January 30, 2017 updated by: Regeneron Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen.
The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
803
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sofia, Bulgaria
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Varna, Bulgaria
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Quebec, Canada
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British Columbia
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Victoria, British Columbia, Canada
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Ontario
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Trois-Rivieres, Quebec, Canada
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Becsi ut
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Budapest, Becsi ut, Hungary
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HBM
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Debrecen, HBM, Hungary
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Sz-sz-b_m
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Nyiregyhaza, Sz-sz-b_m, Hungary
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Veszprém
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Ajka, Veszprém, Hungary
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Zala
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Nagykanizsa, Zala, Hungary
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Zalaegerszeg, Zala, Hungary
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Holon, Israel
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Tel Hashomer, Israel
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IL
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Tel Hashomer, IL, Israel
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ISR
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Safed, ISR, Israel
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South
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Ofakim, South, Israel
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Oslo, Norway
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Akershus
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Skedsmokorset, Akershus, Norway
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Lucenec, Slovakia
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Považská Bystrica, Slovakia
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Presov
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Svidnik, Presov, Slovakia
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SK
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Bratislava, SK, Slovakia
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SR
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Bratislava, SR, Slovakia
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Berkshire
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Worton Grange, Reading, Berkshire, United Kingdom
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Birmingham
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Edgbaston, Birmingham, United Kingdom
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Cardiff
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Llanishen, Cardiff, United Kingdom
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Lancashire
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Choley, Lancashire, United Kingdom
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Liverpool
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Waterloo, Liverpool, United Kingdom
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Manchester
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Lloyd Street North, Manchester, United Kingdom
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Scotland
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Glasgow, Scotland, United Kingdom
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Arizona
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Chandler, Arizona, United States
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Goodyear, Arizona, United States
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California
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Carmichael, California, United States
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Fresno, California, United States
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West Hills, California, United States
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Wildomar, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Golden, Colorado, United States
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Florida
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Safety Harbor, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Idaho
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Illinois
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Indiana
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa
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Iowa City, Iowa, United States
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Kansas
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Kansas City, Kansas, United States
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Kentucky
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Louisville, Kentucky, United States
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Louisiana
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Monroe, Louisiana, United States
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Maine
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Auburn, Maine, United States
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Massachusetts
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Methuen, Massachusetts, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Missouri
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St. Louis, Missouri, United States
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New York
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Rochester, New York, United States
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North Carolina
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Farmville, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilson, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Marion, Ohio, United States
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Oklahoma
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Tulsa, Oklahoma, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Tennessee
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Knoxville, Tennessee, United States
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Texas
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Utah
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Orem, Utah, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Washington
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wisconsin
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Kenosha, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women > age 18 or legal age of majority with elevated LDL-C
- Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
- Willing and able to comply with clinic visits and study-related procedures
- Provided signed informed consent
Exclusion Criteria:
- Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
- Known history of positive test for human immunodeficiency virus (HIV)
- Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy.
- Participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study.
- Certain laboratory findings obtained during the screening period
The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo Q2W
Two subcutaneous (SC) injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
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Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
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Experimental: Alirocumab 75 mg/ Up 150 mg Q2W
One SC injection of each Alirocumab 75 mg and placebo Q2W with or without stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
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Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Other Names:
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Experimental: Alirocumab 300 mg/ Up 150 mg Q4W
Two SC injections of Alirocumab 150 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks.
Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
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Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis)
Time Frame: From Baseline to Week 24
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Adjusted least squares (LS) means and standard errors at Week 24 and at averaged Week 21 to 24 were obtained from a mixed effect model with repeated measures (MMRM) model to account for missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in this model (ITT analysis).
ITT population (subjects with concomitant statin therapy): all randomized subjects who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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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 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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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 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 24
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Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 24
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Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Apo B ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Apo B ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Non-HDL-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Non-HDL-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
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Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Total-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis
Time Frame: From Baseline to Week 12
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Total-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
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From Baseline to Week 12
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Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis
Time Frame: Up to Week 24
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Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent.
High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk.
Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%.
CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage.
Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model.
ITT population (subjects with or without concomitant statin therapy).
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Up to Week 24
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Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis
Time Frame: Up to Week 24
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Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent.
High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk.
Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%.
CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage.
Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model.
ITT population (subjects with or without concomitant statin therapy).
|
Up to Week 24
|
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL(2.59 mmol/L) (Without Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL(1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL(2.59 mmol/L) (With Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Time Frame: Up to Week 24
|
Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
mITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
Up to Week 24
|
Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data.
All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm
|
From Baseline to Week 24
|
Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
HDL-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
HDL-C ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
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 24 regardless of status on-or off-treatment.
ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 24
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 24
|
Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Apo A1 ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 12
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Apo A1 ITT population (subjects with or without concomitant statin therapy).
Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen.
Hence no statistical comparison was performed for this arm.
|
From Baseline to Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roth EM, Kastelein JJP, Cannon CP, Farnier M, McKenney JM, DiCioccio AT, Brunet A, Manvelian G, Sasiela WJ, Baccara-Dinet MT, Zhao J, Robinson JG. Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial. J Clin Lipidol. 2020 Sep - Oct;14(5):707-719. doi: 10.1016/j.jacl.2020.07.009. Epub 2020 Jul 25.
- Muller-Wieland D, Rader DJ, Moriarty PM, Bergeron J, Langslet G, Ray KK, Manvelian G, Thompson D, Bujas-Bobanovic M, Roth EM. Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5253-5262. doi: 10.1210/jc.2018-02703.
- Roth EM, Moriarty PM, Bergeron J, Langslet G, Manvelian G, Zhao J, Baccara-Dinet MT, Rader DJ; ODYSSEY CHOICE I investigators. A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I. Atherosclerosis. 2016 Nov;254:254-262. doi: 10.1016/j.atherosclerosis.2016.08.043. Epub 2016 Aug 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 20, 2013
First Posted (Estimate)
August 21, 2013
Study Record Updates
Last Update Posted (Actual)
March 21, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R727-CL-1308
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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