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Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo (for alirocumab)
Alirocumab
Lipid-Modifying Therapy (LMT)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who were not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (Week -3).

Exclusion criteria:

  1. LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit in participants with heterozygous familial hypercholesterolemia or in participants with non-familial hypercholesterolemia who had a history of documented coronary heart disease as described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
  2. LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit in participants with non-familial hypercholesterolemia who had a history of documented diseases or other risk factors as categorized in primary prevention category III as described in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
  3. Not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit or between screening and randomization visits.
  4. Age <20 years at the screening visit.

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

Sites / Locations

  • Investigational Site Number 392016
  • Investigational Site Number 392029
  • Investigational Site Number 392024
  • Investigational Site Number 392012
  • Investigational Site Number 392013
  • Investigational Site Number 392032
  • Investigational Site Number 392004
  • Investigational Site Number 392028
  • Investigational Site Number 392002
  • Investigational Site Number 392005
  • Investigational Site Number 392023
  • Investigational Site Number 392009
  • Investigational Site Number 392026
  • Investigational Site Number 392003
  • Investigational Site Number 392011
  • Investigational Site Number 392017
  • Investigational Site Number 392007
  • Investigational Site Number 392006
  • Investigational Site Number 392018
  • Investigational Site Number 392014
  • Investigational Site Number 392019
  • Investigational Site Number 392020
  • Investigational Site Number 392022
  • Investigational Site Number 392030
  • Investigational Site Number 392027
  • Investigational Site Number 392010
  • Investigational Site Number 392015
  • Investigational Site Number 392031
  • Investigational Site Number 392021
  • Investigational Site Number 392025
  • Investigational Site Number 392008
  • Investigational Site Number 392001

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Q2W

Alirocumab 75 mg/Up to 150 mg Q2W

Arm Description

Placebo (for alirocumab) every two weeks (Q2W) added to stable lipid-modifying therapy (LMT).

Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels above pre-specified threshold at Week 8 as defined in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012 i.e. ≥100 mg/dL (2.59 mmol/L) in heFH participants or in non-familial hypercholesterolemia (non-FH) participants who had a history of documented coronary heart disease (CHD) ≥120 mg/dL (3.10 mmol/L) in non-FH participants who had a history of documented diseases or other risk factors as categorized in primary prevention category III

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
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 24 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
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).
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
Adjusted LS means and standard errors at Week 12 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).
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
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).
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
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).
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
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.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis
Calculated LDL-C goal was defined as: <100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. 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 imputation model.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis
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).
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
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.
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
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.
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis
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.

Full Information

First Posted
April 4, 2014
Last Updated
September 27, 2016
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02107898
Brief Title
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia. Secondary Objectives: To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. To evaluate the effect of alirocumab on other lipid parameters. To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment. To evaluate the safety and tolerability of alirocumab. To evaluate the development of anti-alirocumab antibodies. To evaluate the pharmacokinetics of alirocumab.
Detailed Description
Total duration per participant of approximately 63 weeks (14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
Placebo (for alirocumab) every two weeks (Q2W) added to stable lipid-modifying therapy (LMT).
Arm Title
Alirocumab 75 mg/Up to 150 mg Q2W
Arm Type
Experimental
Arm Description
Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels above pre-specified threshold at Week 8 as defined in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012 i.e. ≥100 mg/dL (2.59 mmol/L) in heFH participants or in non-familial hypercholesterolemia (non-FH) participants who had a history of documented coronary heart disease (CHD) ≥120 mg/dL (3.10 mmol/L) in non-FH participants who had a history of documented diseases or other risk factors as categorized in primary prevention category III
Intervention Type
Drug
Intervention Name(s)
Placebo (for alirocumab)
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
SAR236553, REGN727, Praluent
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Intervention Type
Drug
Intervention Name(s)
Lipid-Modifying Therapy (LMT)
Intervention Description
Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
Description
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 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Description
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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
Description
Adjusted LS means and standard errors at Week 12 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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Description
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.
Time Frame
From baseline to Week 24
Title
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Description
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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Description
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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis
Description
Calculated LDL-C goal was defined as: <100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. 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 imputation model.
Time Frame
Up to Week 24
Title
Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis
Description
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).
Time Frame
Up to Week 24
Title
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Other Pre-specified Outcome Measures:
Title
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Description
Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 52 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).
Time Frame
From Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who were not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (Week -3). Exclusion criteria: LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit in participants with heterozygous familial hypercholesterolemia or in participants with non-familial hypercholesterolemia who had a history of documented coronary heart disease as described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit in participants with non-familial hypercholesterolemia who had a history of documented diseases or other risk factors as categorized in primary prevention category III as described in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit or between screening and randomization visits. Age <20 years at the screening visit. The above information is not intended to contain all considerations relevant to a participants' potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392016
City
Adachi-Ku
Country
Japan
Facility Name
Investigational Site Number 392029
City
Adachi-Ku
Country
Japan
Facility Name
Investigational Site Number 392024
City
Aki-Gun
Country
Japan
Facility Name
Investigational Site Number 392012
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392013
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392032
City
Fukui-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Hakusan-Shi
Country
Japan
Facility Name
Investigational Site Number 392028
City
Kaga-Shi
Country
Japan
Facility Name
Investigational Site Number 392002
City
Kanazawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392005
City
Kanazawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392023
City
Kawanishi-Shi
Country
Japan
Facility Name
Investigational Site Number 392009
City
Kisarazu-Shi
Country
Japan
Facility Name
Investigational Site Number 392026
City
Kitakyushu-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Komatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392011
City
Kuki-Shi
Country
Japan
Facility Name
Investigational Site Number 392017
City
Matsumoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392007
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392006
City
Moriya-Shi
Country
Japan
Facility Name
Investigational Site Number 392018
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392014
City
Oota-Ku
Country
Japan
Facility Name
Investigational Site Number 392019
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392020
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392022
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392030
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392027
City
Oyabe-Shi
Country
Japan
Facility Name
Investigational Site Number 392010
City
Saitama-Shi
Country
Japan
Facility Name
Investigational Site Number 392015
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392031
City
Shizuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392021
City
Suita-Shi
Country
Japan
Facility Name
Investigational Site Number 392025
City
Takamatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392008
City
Tsuchiura-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Yamagata-Shi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27452202
Citation
Teramoto T, Kobayashi M, Tasaki H, Yagyu H, Higashikata T, Takagi Y, Uno K, Baccara-Dinet MT, Nohara A. Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High Cardiovascular Risk With Hypercholesterolemia Not Adequately Controlled With Statins - ODYSSEY JAPAN Randomized Controlled Trial. Circ J. 2016 Aug 25;80(9):1980-7. doi: 10.1253/circj.CJ-16-0387. Epub 2016 Jul 22. Erratum In: Circ J. 2016;80(11):2414.
Results Reference
result
PubMed Identifier
33078867
Citation
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

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