Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173570
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2023-12-08
Brief Title:
A Study to Assess the Efficacy Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase IIb Multicenter Randomized Parallel-Group Double-Blind Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy Safety and Tolerability of AZD0780 in Participants With Dyslipidemia
Status:
COMPLETED
Status Verified Date:
2024-10
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:
PURSUIT
Brief Summary:
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein LDL-C levels compared with placebo in participants with dyslipidemia The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated The concentration of AZD0780 in blood at specific timepoints is measured and the safety and tolerability of AZD0780 will be evaluated There is a follow-up after end of treatment but expanded access is not available The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level in percent change from baseline up to week 12
Detailed Description:
None
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