Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03317002
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2017-10-05
Brief Title:
AZD5718 Phase IIa Study to Evaluate Efficacy Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease CAD
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 12-week Randomized Single-blind Placebo-controlled Multi-centre Parallel Group Phase IIa Study to Evaluate Efficacy Safety and Tolerability of Oral AZD5718 After 4 and 12-weeks of Treatment in Patients With Coronary Artery Disease CAD
Status:
COMPLETED
Status Verified Date:
2021-06
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:
FLAVOUR
Brief Summary:
This is a randomized single-blind placebo-controlled parallel-group multicentre study in patients with CAD The study will be conducted at approximately 10 centres in 3 countries Approximately 138 CAD patients will be randomized to AZD5718 or placebo treatment duration 12 weeks
Detailed Description:
This is a randomized single-blind placebo-controlled parallel-group multicentre study in patients with CAD The study will be conducted at approximately 10 centres in 3 countries Denmark Finland and Sweden
Patients suitable for the study will be identified and screened for eligibility after being hospitalized for Acute Coronary Syndrome ACS Visit 1 comprising ST Elevation Myocardial Infarction STEMI or Non-ST Elevation Myocardial Infarction non-STEMI At Visit 1 after signing informed consent study measurements will take place at days 1 2 3 and 5 post ACS where feasible It is planned that approximately 138 CAD patients will be randomized to ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with 12 weeks treatment For supporting dose selection in future studies a treatment arm with 28 randomized patients receiving AZD5718 Dose A is included in the study The study was originally designed to be a 4-week study and was amended to be a 12-week study Therefore the total number of patients is greater than required for a 12 weeks study about 100 since some patients will only have 4 weeks of treatment
An evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve CFVR measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab
On Day 1 Visit 2 7 to 28 days after the ACS event patients willing to participate in the study will complete the screening procedure and if eligible be randomized Treatment duration will be 12 weeks During the treatment phase patients will come in to the clinic for study measurements at 2 weeks visit 3 4 weeks visit 4 8 weeks visit 4b and 12 weeks visit 4c
A follow-up visit Visit 5 will be performed at 4 weeks 4 days after last dose in order to ensure safety and well-being of the patients
Patients suitable for the study will be identified and screened for eligibility after being hospitalized for Acute Coronary Syndrome ACS Visit 1 comprising ST Elevation Myocardial Infarction STEMI or Non-ST Elevation Myocardial Infarction non-STEMI At Visit 1 after signing informed consent study measurements will take place at days 1 2 3 and 5 post ACS where feasible It is planned that approximately 138 CAD patients will be randomized to ensure at least 66 evaluable patients receiving AZD5718 Dose B or placebo are included with 12 weeks treatment For supporting dose selection in future studies a treatment arm with 28 randomized patients receiving AZD5718 Dose A is included in the study The study was originally designed to be a 4-week study and was amended to be a 12-week study Therefore the total number of patients is greater than required for a 12 weeks study about 100 since some patients will only have 4 weeks of treatment
An evaluable patient is defined as a patient with a valid Coronary Flow Velocity Reserve CFVR measurement at Visit 2 and one post baseline visit as judged by the CFVR Core lab
On Day 1 Visit 2 7 to 28 days after the ACS event patients willing to participate in the study will complete the screening procedure and if eligible be randomized Treatment duration will be 12 weeks During the treatment phase patients will come in to the clinic for study measurements at 2 weeks visit 3 4 weeks visit 4 8 weeks visit 4b and 12 weeks visit 4c
A follow-up visit Visit 5 will be performed at 4 weeks 4 days after last dose in order to ensure safety and well-being of the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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