Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267560
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-12
Brief Title:
Lpa Lowering Study of Pelacarsen TQJ230 in US BlackAfrican American and Hispanic Participants With Elevated Lpa and Established ASCVD
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Efficacy Safety and Tolerability of Pelacarsen TQJ230 in US BlackAfrican American Hispanic Patient Populations With Elevated Lpa and Established Atherosclerotic Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Study CTQJ230A12303 is a randomized double-blind placebo-controlled Phase IIIb study to evaluate the efficacy safety and tolerability of pelacarsen TQJ230 80 mg sc QM compared with placebo sc QM in US BlackAfrican American and Hispanic participants with established ASCVD and elevated levels of Lpa who are treated for cardiovascular CV risk factors according to local practiceguidelines for the reduction of cardiovascular risk
Detailed Description:
CTQJ230A12303 is a randomized double-blind placebo-controlled multi-center Phase IIIb study to evaluate the efficacy measured by reduction of the Lpa levels and safety of pelacarsen TQJ230 80mg sc QM compared to placebo in US BlackAfrican American and US Hispanic participants with established atherosclerotic cardiovascular disease ASCVD as evidenced by history of coronary heart disease cerebrovascular disease or symptomatic peripheral artery disease PAD and elevated levels of Lpa
The study will consist of a screening period of approximately 30 days followed by a Guideline recommended SoC implementation period of approximately 30 days if required and a doubleblind treatment period of 12 months There will be a post-treatment follow-up period of 16 weeks
The study will consist of a screening period of approximately 30 days followed by a Guideline recommended SoC implementation period of approximately 30 days if required and a doubleblind treatment period of 12 months There will be a post-treatment follow-up period of 16 weeks
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?:
None
Is an FDA AA801 Violation?:
None