HypercholesterolemiaPhase 3ODYSSEY EASTNCT02715726
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
A Phase 3 study testing Alirocumab, ezetimibe and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 62 sites in 3 countries.
Trial summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Alirocumab, ezetimibe and atorvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 615 participants
- Where
- 62 sitesin 3 countries
- Study dates
- 27 Jul 2016to 6 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).
Who cannot join
- Participants without established CHD or CHD risk equivalents.
- LDL-C <70 mg/dL (<1.81 mmol/L) at the screening visit (Week -3) in participants with history of documented CV disease.
- LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants without history of documented CV disease.
- Change in statin dose or dose regimen from screening to randomization.
- Currently taking a statin other than atorvastatin, rosuvastatin, or simvastatin.
- Atorvastatin, rosuvastatin, or simvastatin was not taken daily or not taken at a registered dose.
Show all 10Show fewer
- Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg.
- Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty acid (at doses ≥1000 mg daily), nicotinic acid, fibrates, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (Week -3).
- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
62 sites in 3 countries.
62 sites in 3 countries
China41 sites
Investigational Site Number 1560027
Beijing, 100029
Investigational Site Number 1560043
Beijing, 100034
Investigational Site Number 1560039
Beijing, 100053
Investigational Site Number 1560012
Beijing, 100730
Investigational Site Number 1560018
Beijing, 100730
Investigational Site Number 1560006
Changchun, 130021
Investigational Site Number 1560020
Changchun, 130021
Investigational Site Number 1560023
Changsha, 410011
Investigational Site Number 1560030
Fuzhou, 354200
Investigational Site Number 1560005
Guangzhou, 510080
Investigational Site Number 1560040
Guangzhou, 510080
Investigational Site Number 1560025
Guangzhou, 510120
Investigational Site Number 1560048
Hangzhou, 310014
Investigational Site Number 1560037
Hangzhou, 310015
Investigational Site Number 1560008
Hangzhou, 310016
Investigational Site Number 1560014
Hohhot, 010017
Investigational Site Number 1560016
Jinan, 250013
Investigational Site Number 1560044
Lanzhou, 730000
Investigational Site Number 1560028
Nanchang, 330006
Investigational Site Number 1560045
Nanjing, 210006
Investigational Site Number 1560017
Nanjing, 210008
Investigational Site Number 1560031
Nanjing, 210011
Investigational Site Number 1560035
Nanning, 530031
Investigational Site Number 1560029
Shanghai, 200025
Investigational Site Number 1560041
Shanghai, 200040
Investigational Site Number 1560053
Shanghai, 201199
Investigational Site Number 1560009
Shenyang, 110004
Investigational Site Number 1560001
Shenyang, 110016
Investigational Site Number 1560042
Shenyang, 110016
Investigational Site Number 1560036
Shenzhen, 518036
Investigational Site Number 1560056
Siping, 136000
Investigational Site Number 1560021
Taiyuan, 030001
Investigational Site Number 1560002
Tianjin, 300052
Investigational Site Number 1560022
Tianjin, 300121
Investigational Site Number 1560052
Tianjin, 300140
Investigational Site Number 1560055
Wenzhou, 325000
Investigational Site Number 1560003
Wuhan, 430022
Investigational Site Number 1560004
Xi'an, 710061
Investigational Site Number 1560019
Xuzhou, 221002
Investigational Site Number 1560054
Yinchuan, 750004
Investigational Site Number 1560057
Zhanjiang, 524001
India17 sites
Investigational Site Number 3560017
Belagavi, 590010
Investigational Site Number 3560001
Gūrgaon, 122001
Investigational Site Number 3560003
Hubli, 580021
Investigational Site Number 3560010
Kolkata, 700020
Investigational Site Number 3560019
Kolkata, 700073
Investigational Site Number 3560020
Mangalore, 575002
Investigational Site Number 3560006
Mumbai
Investigational Site Number 3560007
Nagpur, 440003
Investigational Site Number 3560004
Nagpur, 440010
Investigational Site Number 3560008
Nagpur, 440012
Investigational Site Number 3560016
Nagpur, 440012
Investigational Site Number 3560014
New Delhi, 110002
Investigational Site Number 3560005
Pune, 411001
Investigational Site Number 3560011
Pune, 411001
Investigational Site Number 3560013
Surat, 395002
Investigational Site Number 3560015
Vijayawada, 520008
Investigational Site Number 3560012
Vijaywada, 520002
Thailand4 sites
Investigational Site Number 7640004
Bangkok, 10400
Investigational Site Number 7640003
Bangkok Noi, 10700
Investigational Site Number 7640001
Muang, 50200
Investigational Site Number 7640002
Pratumwan, 10400
About this study
Official title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk.
Read more
Secondary Objectives:
- To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment.
- To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp[a]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics (PK) of alirocumab.
Read the detailed description
The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.
- Conditions
- Hypercholesterolemia
- Being tested
- Alirocumab, Placebo for alirocumab, ezetimibe, placebo for ezetimibe, atorvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
Also called SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous
Placebo for alirocumabDrug
Pharmaceutical form:solution Route of administration: subcutaneous
ezetimibeDrug
Pharmaceutical form:capsule Route of administration: oral
placebo for ezetimibeDrug
Pharmaceutical form:capsule Route of administration: oral
atorvastatinDrug
Pharmaceutical form:tablet Route of administration: oral
rosuvastatinDrug
Pharmaceutical form:tablet Route of administration: oral
simvastatinDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe 10 mg | Active comparator | Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT). Receives: Drug: Placebo for alirocumab; Drug: ezetimibe; Drug: atorvastatin; Drug: rosuvastatin; Drug: simvastatin |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | Experimental | Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]) at Week 8. Receives: Drug: Alirocumab; Drug: placebo for ezetimibe; Drug: atorvastatin; Drug: rosuvastatin; Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis
Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis 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).
Measured: From Baseline to Week 24
Secondary outcomes (21)
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Measured: From Baseline to Week 24
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Measured: From Baseline to Week 12
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Measured: From Baseline to Week 24
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 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 24
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Measured: From Baseline to Week 24
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
Measured: Up to Week 24
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis
Adjusted percentages at Week 24 were obtained from multiple imputation approach including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Measured: Up to Week 24
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling 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.
Measured: From Baseline to Week 24
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 24
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis
Adjusted means and standard errors at Week 24 were obtained by using 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.
Measured: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 24
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 including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis
Adjusted means and standard errors at Week 12 were obtained by using multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start27 Jul 2016
- Primary completion6 Aug 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715726
- Sponsor's protocol ID
- EFC13889
- Other IDs
- U1111-1150-8859
- Acronym
- ODYSSEY EAST
- Status last verified
- Sep 2019
- First submitted
- 16 Mar 2016
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Han Y, Chen J, Chopra VK, Zhang S, Su G, Ma C, Huang Z, Ma Y, Yao Z, Yuan Z, Zhao Q, Kuanprasert S, Baccara-Dinet MT, Manvelian G, Li J, Chen R. ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand. J Clin Lipidol. 2020 Jan-Feb;14(1):98-108.e8. doi: 10.1016/j.jacl.2019.10.015. Epub 2019 Nov 18.
PubMed 31882376
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
- ClinicalTrials.gov ID
- NCT02715726
- Acronym / sponsor ID
- ODYSSEY EAST / EFC13889
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk.
Secondary Objectives:
- To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment.
- To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp[a]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics (PK) of alirocumab.
Detailed description
The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe 10 mg | Active comparator | Drug: Placebo for alirocumab, Drug: ezetimibe, Drug: atorvastatin, Drug: rosuvastatin, Drug: simvastatinOral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT). |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | Experimental | Drug: Alirocumab, Drug: placebo for ezetimibe, Drug: atorvastatin, Drug: rosuvastatin, Drug: simvastatinSubcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]) at Week 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).
Key exclusion criteria (10 listed)
- Participants without established CHD or CHD risk equivalents.
- LDL-C <70 mg/dL (<1.81 mmol/L) at the screening visit (Week -3) in participants with history of documented CV disease.
- LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in participants without history of documented CV disease.
- Change in statin dose or dose regimen from screening to randomization.
- Currently taking a statin other than atorvastatin, rosuvastatin, or simvastatin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlirocumabAlso: SAR236553 (REGN727)Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Alirocumab 75 mg Q2W/up to 150 mg Q2W |
| Placebo for alirocumabPharmaceutical form:solution Route of administration: subcutaneous | Drug | Ezetimibe 10 mg |
| ezetimibePharmaceutical form:capsule Route of administration: oral | Drug | Ezetimibe 10 mg |
| placebo for ezetimibePharmaceutical form:capsule Route of administration: oral | Drug | Alirocumab 75 mg Q2W/up to 150 mg Q2W |
| atorvastatinPharmaceutical form:tablet Route of administration: oral | Drug | Alirocumab 75 mg Q2W/up to 150 mg Q2W, Ezetimibe 10 mg |
| rosuvastatinPharmaceutical form:tablet Route of administration: oral | Drug | Alirocumab 75 mg Q2W/up to 150 mg Q2W, Ezetimibe 10 mg |
| simvastatinPharmaceutical form:tablet Route of administration: oral | Drug | Alirocumab 75 mg Q2W/up to 150 mg Q2W, Ezetimibe 10 mg |
Primary outcome
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis
Time frame: From Baseline to Week 24
Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis 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).
21 secondary outcomes
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis
Time frame: Up to Week 24
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis
Time frame: Up to Week 24
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis
Time frame: From Baseline to Week 24
Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis
Time frame: From Baseline to Week 12
Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis
Time frame: From Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31882376Han Y, Chen J, Chopra VK, Zhang S, Su G, Ma C, Huang Z, Ma Y, Yao Z, Yuan Z, Zhao Q, Kuanprasert S, Baccara-Dinet MT, Manvelian G, Li J, Chen R. ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand. J Clin Lipidol. 2020 Jan-Feb;14(1):98-108.e8. doi: 10.1016/j.jacl.2019.10.015. Epub 2019 Nov 18.
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Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
62 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alirocumab, ezetimibe and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 62 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in China, India, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis (time frame: From Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.