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An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (ODYSSEY KIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890992
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the pharmacokinetics profile of alirocumab.
  • To evaluate the effects of alirocumab on other lipid parameters.

Condition or disease Intervention/treatment Phase
Hypercholesterolaemia Drug: alirocumab SAR236553 (REGN727) Drug: statins Drug: ezetimibe Drug: cholestyramine Drug: fenofibrate Drug: omega-3 fatty acids Drug: nicotinic acid Phase 2

Detailed Description:

For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6 (+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).

For Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 [+1] weeks, open-label dose finding treatment period: 12 weeks).

Optional extension period: up to a maximum of 2 years for the first participants enrolled in Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled in Cohort 4.

For all participants who declined participation in the phase 3 study, their last alirocumab injection was on December 2018.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Cohort 1 - Alirocumab 30 mg Q2W: <50 kg

Period 1: Participants with body weight less than (<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram(mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).

Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until they started receiving dose matching to Cohort 2 dosage including dose adjustment to body weight as required. Cohort 2 dosage was: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg

Period 1: Participants with body weight greater than or equal to (>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 2 - Alirocumab 40 mg Q2W: <50 kg

Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg

Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.

Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 3 - Alirocumab 75 mg Q4W: <50 kg

Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.

Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg

Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.

Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 4 - Alirocumab 150 mg Q4W: <50 kg

Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.

Period 2: Participants with body weight < 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral

Experimental: Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg

Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.

Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution Route of administration: subcutaneous injection
Other Name: Praluent

Drug: statins
Pharmaceutical form: tablet Route of administration: oral

Drug: ezetimibe
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:tablet Route of administration: oral

Drug: fenofibrate
Pharmaceutical form: tablet Route of administration: oral

Drug: omega-3 fatty acids
Pharmaceutical form: tablet Route of administration: oral

Drug: nicotinic acid
Pharmaceutical form: tablet Route of administration: oral




Primary Outcome Measures :
  1. Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Percent change in calculated LDL-C was defined as 100*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period & within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 & 2) or +35 days (for Cohorts 3 & 4). Adjusted Least-squares (LS) mean & standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W [<50 kg], 40 mg Q2W [<50 kg], 50 mg Q2W [>=50 kg], 75 mg Q2W [>=50 kg], 75 mg Q4W [<50 kg],150 mg Q4W [>=50 kg], 150 mg Q4W [<50 kg] and 300 mg Q4W ([>=50 kg] dose), time point & dose/dose regimen-by-time point interaction.


Secondary Outcome Measures :
  1. Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.

  2. Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8 [ Time Frame: At Week 8 ]
    Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  3. Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8 [ Time Frame: At Week 8 ]
    Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  4. Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4 [ Time Frame: Baseline, Week 12 ]
    Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.

  5. Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.

  6. Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  7. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  8. Percent Change From Baseline in Lipoprotein(a) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  9. Percent Change From Baseline in Fasting Triglyceride at Week 8 [ Time Frame: Baseline, Week 8 ]
    Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  10. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  11. Percent Change From Baseline in Apolipoprotein A-1 at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  12. Absolute Change From Baseline in Apolipoprotein B at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  13. Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  14. Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  15. Absolute Change From Baseline in Lipoprotein(a) at Week 8 [ Time Frame: Baseline, Week 8 ]
    Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  16. Absolute Change From Baseline in HDL-C at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  17. Absolute Change From Baseline in Fasting Triglyceride at Week 8 [ Time Frame: Baseline, Week 8 ]
    Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.

  18. Absolute Change From Baseline in Apolipoprotein A-1 at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.

  19. Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8 [ Time Frame: Baseline, Week 8 ]
    Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Children and adolescent male and female participants aged of 8 to 17 years at the time of signed informed consent. For Russia only: Male and female participants aged >=12 and <=17 years at the time of signed informed consent.
  • Participants with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
  • Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
  • Participants with calculated LDL-C greater than or equal to 130 mg/dL (>=3.37 mmol/L) at the screening visit.
  • Participants with body weight greater than or equal to 25 kg.
  • Participants aged of 8 to 9 years to be at Tanner stage 1 and participants aged of 10 to 17 years to be at least at Tanner stage 2 in their development.
  • A signed informed consent indicating parental permission with or without participant assent.

Exclusion criteria:

  • Participant with secondary hyperlipidemia.
  • Diagnosis of homozygous familial hypercholesterolemia.
  • Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
  • Known history of type 1 or type 2 diabetes mellitus.
  • Known history of thyroid disease.
  • Known history of hypertension.
  • Fasting triglycerides >350 mg/dL (3.95 mmol/L).
  • Severe renal impairment (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m^2).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN).
  • Creatinine phosphokinase (CPK) >3 x ULN.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890992


Locations
Layout table for location information
United States, Missouri
Investigational Site Number 8400002
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Investigational Site Number 8400005
Charlotte, North Carolina, United States, 28204
United States, Ohio
Investigational Site Number 8400001
Cincinnati, Ohio, United States, 45229
Canada
Investigational Site Number 1240001
Quebec, Canada, G1V 4W2
Czechia
Investigational Site Number 2030001
Brno, Czechia, 62500
Investigational Site Number 2030003
Praha 5 - Motol, Czechia, 15006
Investigational Site Number 2030002
Zlin, Czechia, 76275
France
Investigational Site Number 2500001
Bron Cedex, France, 69677
Netherlands
Investigational Site Number 5280001
Amsterdam, Netherlands, 1105AZ
Norway
Investigational Site Number 5780001
Oslo, Norway
Russian Federation
Investigational Site Number 6430001
Kemerovo, Russian Federation, 650002
Investigational Site Number 6430004
Saint-Petersburg, Russian Federation, 194100
South Africa
Investigational Site Number 7100001
Parow, South Africa, 7500
Spain
Investigational Site Number 7240004
A Coruna, Spain, 15001
Investigational Site Number 7240001
Madrid, Spain, 28009
Sweden
Investigational Site Number 7520001
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] December 11, 2017
Statistical Analysis Plan  [PDF] May 15, 2018

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02890992    
Other Study ID Numbers: DFI14223
2015-003766-85 ( EudraCT Number )
U1111-1178-4764 ( Other Identifier: UTN )
First Posted: September 7, 2016    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Nicotinic Acids
Niacin
Niacinamide
Ezetimibe
Cholestyramine Resin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents