Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02289963
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2014-11-10
Brief Title:
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy in South Korea and Taiwan
Status:
COMPLETED
Status Verified Date:
2017-06
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:
None
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 with or without other lipid-modifying therapy LMT in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan
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 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 triglycerides TGs and apolipoprotein A-1 Apo A-1
To evaluate the safety and tolerability of alirocumab
To evaluate the development of anti-alirocumab antibodies ADA
To demonstrate the reduction of low-density lipoprotein cholesterol LDL-C by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy LMT in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan
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 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 triglycerides TGs and apolipoprotein A-1 Apo A-1
To evaluate the safety and tolerability of alirocumab
To evaluate the development of anti-alirocumab antibodies ADA
Detailed Description:
The maximum study duration was approximately 35 weeks per participant including up to 3 weeks screening period 24 weeks double-blind treatment period and 8 weeks follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U1111-1157-3294 | OTHER | UTN | None |