AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
FLAVOUR
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)
1 other identifier
interventional
129
3 countries
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 coronary-artery-disease
Started Oct 2017
Typical duration for phase_2 coronary-artery-disease
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedStudy Start
First participant enrolled
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2020
CompletedResults Posted
Study results publicly available
June 30, 2021
CompletedJune 30, 2021
June 1, 2021
2.4 years
October 5, 2017
March 30, 2021
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Creatinine-normalized u-LTE4 at Week 4
Creatinine-normalized u-LTE4 is calculated as uLTE4/creatinine
Baseline and 4 weeks
Secondary Outcomes (10)
Change From Baseline in Creatinine-normalized u-LTE4 at Week 12
Baseline and 12 weeks
Change From Baseline in CFVR at Week 12
Baseline and 12 weeks
Change From Baseline in CFVR at Week 4
Baseline and 4 weeks
Summary of Plasma Concentrations of AZD5718
16 weeks
Change From Baseline in LAD Hypereamic Flow at 4 Weeks
Baseline and 4 weeks
- +5 more secondary outcomes
Study Arms (3)
AZD5718 Dose A
EXPERIMENTALAZD5718 Dose A once daily
AZD5718 Dose B
EXPERIMENTALAZD5718 Dose B once daily
Placebo
PLACEBO COMPARATORMatching placebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- Males and females of non-childbearing potential
- Age ≥18 to ≤75
- Body Mass Index (BMI) ≥18 to ≤35 kg/m2
- CAD patients, here defined as:
- ACS 7-28 days prior to study randomization (ACS defined as STEMI, non STEMI event documented by Electrocardiogram (ECG), cardiac enzymes \[troponin\] and angiogram) Provision of signed and dated, written informed consent prior to any study specific procedures
You may not qualify if:
- Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) Diabetes
- Control and Complications Trial (DCCT)\> 9% or International Federation of Clinical Chemistry (IFCC) \>74.9 mmol/mol
- Patients with atrial fibrillation (chronic or current) or history of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia or sick sinus syndrome or Atrioventricular blockage degree 2-3
- Prior coronary artery by-pass graft (Coronary artery bypass grafting) to Left Anterior Descending artery (LAD)
- Left ventricle ejection fraction \< 30%
- Unacceptable level of angina despite maximal medical therapy or unstable angina at entry
- Canadian Cardiovascular Society (CCS) ≥ 3 (Visit 1 or Visit 2)
- Stroke within the previous 6 months from ACS or ongoing treatment with Persantin or Asasantin
- Chronic use of anticoagulants on therapeutic dose (not including thrombosis prophylaxis) during the study
- Planned additional cardiac intervention (e.g., Percutaneous coronary intervention (PCI), Coronary artery bypass grafting (CABG) within next 6 months
- New York Heart Association (NYHA) class III-IV heart failure or decompensated heart failure at discharge or hospitalization for exacerbation of chronic heart failure within the previous 3 months from ACS
- Previously known severe renal disease (Chronic Kidney Disease (CKD) stage 4 or 5) or previously known creatinine clearance calculated by Cockcroft Gault equation \<30 ml/min\*m2
- Known allergy to adenosine and mannitol, or experience of previous adverse effects of adenosine stress testing.
- Participation in another interventional clinical study with an investigational pharmaceutical product during the last 3 months also including drug eluting stents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (9)
Research Site
Aarhus, 8200, Denmark
Research Site
Frederiksberg, 2000, Denmark
Research Site
Odense C, 5000, Denmark
Research Site
Kuopio, 70210, Finland
Research Site
Turku, 20520, Finland
Research Site
Gothenburg, 413 45, Sweden
Research Site
Lund, 222 42, Sweden
Research Site
Stockholm, 171 76, Sweden
Research Site
Uppsala, 75185, Sweden
Related Publications (1)
Prescott E, Angeras O, Erlinge D, Grove EL, Hedman M, Jensen LO, Pernow J, Saraste A, Akerblom A, Svedlund S, Rudvik A, Knochel J, Lindstedt EL, Garkaviy P, Gan LM, Gabrielsen A. Safety and efficacy of the 5-lipoxygenase-activating protein inhibitor AZD5718 in patients with recent myocardial infarction: The phase 2a FLAVOUR study. Int J Cardiol. 2022 Oct 15;365:34-40. doi: 10.1016/j.ijcard.2022.07.016. Epub 2022 Jul 14.
PMID: 35842004DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2017
First Posted
October 23, 2017
Study Start
October 30, 2017
Primary Completion
April 8, 2020
Study Completion
April 8, 2020
Last Updated
June 30, 2021
Results First Posted
June 30, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.