Back to resultsEfficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin (ODYSSEY-NIPPON)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Alirocumab
Placebo
Atorvastatin
Non-statin Lipid-Modifying Therapy
Diet Alone
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Non-statin LMT, Low dose statin
Eligibility Criteria
Inclusion criteria :
Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.
Exclusion criteria:
- LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease.
- LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
- Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period.
- Fasting serum TGs >400 mg/dL (>4.52 mmol/L) at the screening period.
- Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 392028
- Investigational Site Number 392007
- Investigational Site Number 392029
- Investigational Site Number 392014
- Investigational Site Number 392023
- Investigational Site Number 392013
- Investigational Site Number 392010
- Investigational Site Number 392024
- Investigational Site Number 392004
- Investigational Site Number 392015
- Investigational Site Number 392005
- Investigational Site Number 392032
- Investigational Site Number 392017
- Investigational Site Number 392003
- Investigational Site Number 392018
- Investigational Site Number 392009
- Investigational Site Number 392006
- Investigational Site Number 392011
- Investigational Site Number 392019
- Investigational Site Number 392025
- Investigational Site Number 392027
- Investigational Site Number 392030
- Investigational Site Number 392016
- Investigational Site Number 392001
- Investigational Site Number 392008
- Investigational Site Number 392012
- Investigational Site Number 392002
- Investigational Site Number 392031
- Investigational Site Number 392020
- Investigational Site Number 392022
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Alirocumab 150 mg Q4W
Alirocumab 150 mg Q2W
Placebo Q2W
Arm Description
Double-blind treatment period(DBTP):participants received Alirocumab 150 mg subcutaneous injection every 4 week(Q4W) alternating with placebo(for alirocumab)Q4W added to lowest-strength statin therapy(atorvastatin 5 mg daily),stable non-statin LMT/diet therapy alone for 12weeks. Participants completed DBTP,entered open-label treatment period(OLTP),received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg every 2 weeks(Q2W) at Week 24(OLTP:Week 12),when targeted LDL-C level at Week 20 not achieved as Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012:1) ≥100 mg/dL(2.59 mmol/L) in heterozygous familial hypercholesterolemia (heFH) participants/non-familial hypercholesterolemia (non-FH)participants with history of documented coronary heart disease;2) ≥120 mg/dL(3.10 mmol/L)in non-FH participants with history of documented diseases/other risk factors as categorized in primary prevention category III)
In DBTP, participants received Alirocumab 150 mg subcutaneous (SC) injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when targeted LDL-C levels at Week 20 were not achieved i.e. LDL-C ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) according to Japan Atherosclerosis Society(JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when targeted LDL-C levels at Week 20 were not achieved i.e. LDL-C ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis
Adjusted Least-squares (LS) means and standard errors at Week 12 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 12 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 12- On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 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 12 regardless of status on- or off-treatment and assigning a weight of 0.5 for Week 10 and 12 time points.
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection) and assigning a weight of 0.5 for Week 10 and 12 time points.
Percent Change From Baseline in Apolipoprotein B (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 12 regardless of status on- or off-treatment.
Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data at from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (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 12 regardless of status on- or off-treatment.
Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Percent Change From Baseline in Total Cholesterol (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 12 regardless of status on- or off-treatment.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis
Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heterozygous familiar hypercholesterolemia (heFH) participants or non-familial hypercholesterolemia (non-FH) participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis
Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heFH participants or non-FH participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis
Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (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 12 regardless of status on- or off-treatment.
Percent Change From Baseline in Fasting Triglycerides (TGs) 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 12 regardless of status on- or off-treatment.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) 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 12 regardless of status on- or off-treatment.
Full Information
NCT ID
NCT02584504
First Posted
October 21, 2015
Last Updated
January 3, 2019
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02584504
Brief Title
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Acronym
ODYSSEY-NIPPON
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
January 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia.
Secondary Objective:
To evaluate the effect of two treatment regimens of alirocumab on other lipid parameters: apolipoprotein B (Apo-B), non-high-density lipoprotein cholesterol (non HDL-C), total cholesterol (TC), lipoprotein (a) (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and apolipoprotein A-1 (Apo A-1).
To evaluate the safety and tolerability of alirocumab administration.
To evaluate the development of anti-alirocumab antibodies.
To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration.
To evaluate the long-term safety in participants receiving open-label alirocumab administration.
Detailed Description
The duration of study per participant was approximately 71 weeks consisting of a run-in period (4 weeks), a screening period (3 weeks), a double-blind treatment period (12 weeks), and an open-label treatment period (52 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Non-statin LMT, Low dose statin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alirocumab 150 mg Q4W
Arm Type
Experimental
Arm Description
Double-blind treatment period(DBTP):participants received Alirocumab 150 mg subcutaneous injection every 4 week(Q4W) alternating with placebo(for alirocumab)Q4W added to lowest-strength statin therapy(atorvastatin 5 mg daily),stable non-statin LMT/diet therapy alone for 12weeks. Participants completed DBTP,entered open-label treatment period(OLTP),received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg every 2 weeks(Q2W) at Week 24(OLTP:Week 12),when targeted LDL-C level at Week 20 not achieved as Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012:1) ≥100 mg/dL(2.59 mmol/L) in heterozygous familial hypercholesterolemia (heFH) participants/non-familial hypercholesterolemia (non-FH)participants with history of documented coronary heart disease;2) ≥120 mg/dL(3.10 mmol/L)in non-FH participants with history of documented diseases/other risk factors as categorized in primary prevention category III)
Arm Title
Alirocumab 150 mg Q2W
Arm Type
Experimental
Arm Description
In DBTP, participants received Alirocumab 150 mg subcutaneous (SC) injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when targeted LDL-C levels at Week 20 were not achieved i.e. LDL-C ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) according to Japan Atherosclerosis Society(JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Arm Title
Placebo Q2W
Arm Type
Placebo Comparator
Arm Description
In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks. Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when targeted LDL-C levels at Week 20 were not achieved i.e. LDL-C ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
SAR236553, REGN727
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 5 mg tablet orally.
Intervention Type
Drug
Intervention Name(s)
Non-statin Lipid-Modifying Therapy
Intervention Description
Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.
Intervention Type
Other
Intervention Name(s)
Diet Alone
Intervention Description
Stable cholesterol-lowering diet as background therapy.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis
Description
Adjusted Least-squares (LS) means and standard errors at Week 12 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 12 regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 12
Secondary Outcome Measure Information:
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 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 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 12 regardless of status on- or off-treatment and assigning a weight of 0.5 for Week 10 and 12 time points.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection) and assigning a weight of 0.5 for Week 10 and 12 time points.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Apolipoprotein B (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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data at from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis
Description
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Total Cholesterol (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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Title
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis
Description
Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heterozygous familiar hypercholesterolemia (heFH) participants or non-familial hypercholesterolemia (non-FH) participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.
Time Frame
Up to Week 12
Title
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis
Description
Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heFH participants or non-FH participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).
Time Frame
Up to Week 12
Title
Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis
Description
Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Fasting Triglycerides (TGs) 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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Title
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) 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 12 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 12
Other Pre-specified Outcome Measures:
Title
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis
Time Frame
Baseline, Weeks 20, 24, 36, 48 and 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.
Exclusion criteria:
LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease.
LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period.
Fasting serum TGs >400 mg/dL (>4.52 mmol/L) at the screening period.
Systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).
The above information was not intended to contain all considerations relevant to a participant's 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 392028
City
Ageo-Shi
Country
Japan
Facility Name
Investigational Site Number 392007
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392029
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392014
City
Fukui-Shi
Country
Japan
Facility Name
Investigational Site Number 392023
City
Hachioji-Shi
Country
Japan
Facility Name
Investigational Site Number 392013
City
Itoshima-Shi
Country
Japan
Facility Name
Investigational Site Number 392010
City
Kanazawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392024
City
Kasuga-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Kawanishi-Shi
Country
Japan
Facility Name
Investigational Site Number 392015
City
Kitakyushu-Shi
Country
Japan
Facility Name
Investigational Site Number 392005
City
Komatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392032
City
Matsudo-Shi
Country
Japan
Facility Name
Investigational Site Number 392017
City
Matsumoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392018
City
Morioka-Shi
Country
Japan
Facility Name
Investigational Site Number 392009
City
Moriya-Shi
Country
Japan
Facility Name
Investigational Site Number 392006
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392011
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392019
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392025
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392027
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392030
City
Sakura-Shi
Country
Japan
Facility Name
Investigational Site Number 392016
City
Shinagawa-Ku
Country
Japan
Facility Name
Investigational Site Number 392001
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392008
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392012
City
Shizuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392002
City
Suita-Shi
Country
Japan
Facility Name
Investigational Site Number 392031
City
Suita-Shi
Country
Japan
Facility Name
Investigational Site Number 392020
City
Toyonaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392022
City
Yao-Shi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28623954
Citation
Teramoto T, Kondo A, Kiyosue A, Harada-Shiba M, Ishigaki Y, Tobita K, Kawabata Y, Ozaki A, Baccara-Dinet MT, Sata M. Efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid-lowering therapy or the lowest strength of statin: ODYSSEY NIPPON study design and rationale. Lipids Health Dis. 2017 Jun 17;16(1):121. doi: 10.1186/s12944-017-0513-7.
Results Reference
background
PubMed Identifier
30509509
Citation
Teramoto T, Kiyosue A, Ishigaki Y, Harada-Shiba M, Kawabata Y, Ozaki A, Baccara-Dinet MT, Sata M. Efficacy and safety of alirocumab 150mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON. J Cardiol. 2019 Mar;73(3):218-227. doi: 10.1016/j.jjcc.2018.10.004. Epub 2018 Nov 30.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
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