Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666298
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2020-12-07
Brief Title:
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Placebo-controlled Double-blind Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Status:
COMPLETED
Status Verified Date:
2024-06
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:
ORION-15
Brief Summary:
This was a placebo-controlled double-blind randomized trial in Japanese participants with history of coronary artery disease CAD or participants categorized in high risk by JAS 2017 guideline or Japanese participants with heterozygous familial hypercholesterolemia HeFH and elevated Low-density lipoprotein cholesterol LDL-C despite maximum tolerated dose of statins to evaluate the efficacy safety tolerability and PK of subcutaneous inclisiran injections
Detailed Description:
The expected duration of the participants involvement in the study was approximately 374 days which included screening up to 14 days Day 1 study drug administration two additional injections on Day 90 and Day 270 and the follow-up period to Day 360
The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit
After the primary analysis double-blind treatment period were maintained to Day 360 although specific sponsor members except for blinded monitors were unblinded for the regulatory submission in Japan
The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit
After the primary analysis double-blind treatment period were maintained to Day 360 although specific sponsor members except for blinded monitors were unblinded for the regulatory submission in Japan
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