Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02715726
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-03-16
Brief Title:
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab SAR236553REGN727 Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ODYSSEY EAST
Brief 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 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 eg apolipoprotein B Apo B non-high density lipoprotein cholesterol non-HDL-C total cholesterol TC lipoprotein a Lpa 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
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 eg apolipoprotein B Apo B non-high density lipoprotein cholesterol non-HDL-C total cholesterol TC lipoprotein a Lpa 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1150-8859 | OTHER | UTN | None |