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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04986202




Registration number
NCT04986202
Ethics application status
Date submitted
18/06/2021
Date registered
2/08/2021

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
Scientific title
A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
Secondary ID [1] 0 0
2020-005844-47
Secondary ID [2] 0 0
D6580C00010
Universal Trial Number (UTN)
Trial acronym
ENDEAVOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Preserved Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD4831
Other interventions - Placebo

Experimental: Part A 2.5 mg - AZD4831 2.5 mg

Experimental: Part A 5 mg - AZD4831 5 mg

Placebo comparator: Part A Placebo - Placebo

Experimental: Part B Dose based on Part A - AZD4831 Dose based on Part A

Placebo comparator: Part B Placebo - Placebo


Treatment: Drugs: AZD4831
AZD4831

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kansas City Cardiomyopathy Questionnaire -Total Symptom Score
Timepoint [1] 0 0
Baseline - 16 weeks
Primary outcome [2] 0 0
Kansas City Cardiomyopathy Questionnaire -Total Symptom Score
Timepoint [2] 0 0
Baseline - 24 weeks
Primary outcome [3] 0 0
Six Minute Walk Distance
Timepoint [3] 0 0
Baseline - 16 weeks
Primary outcome [4] 0 0
Six Minute Walk Distance
Timepoint [4] 0 0
Baseline - 24 weeks
Secondary outcome [1] 0 0
Kansas City Cardiomyopathy Questionnaire-Total Symptom Score
Timepoint [1] 0 0
Baseline - 24 and 48 weeks
Secondary outcome [2] 0 0
Six Minute Walk Distance
Timepoint [2] 0 0
Baseline - 24 and 48 weeks
Secondary outcome [3] 0 0
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Timepoint [3] 0 0
Baseline - 16, 24 and 48 weeks
Secondary outcome [4] 0 0
Left ventricular global longitudinal strain (LV-GLS)
Timepoint [4] 0 0
Baseline - 16 and 24 weeks
Secondary outcome [5] 0 0
Left atrial volume index (LAVI)
Timepoint [5] 0 0
Baseline - 16 and 24 weeks
Secondary outcome [6] 0 0
Left ventricular mass index (LVMI)
Timepoint [6] 0 0
Baseline - 16 and 24 weeks
Secondary outcome [7] 0 0
Pharmacokinetics (AZD4831 plasma exposure)
Timepoint [7] 0 0
Day 1, Day 29, Day 85, Day 113, Day 169, Day 336, Day 365
Secondary outcome [8] 0 0
High sensitivity CRP (hsCRP)
Timepoint [8] 0 0
Baseline - 16, 24 and 48 weeks
Secondary outcome [9] 0 0
Interleukin 6 (IL-6)
Timepoint [9] 0 0
Baseline - 16, 24 and 48 weeks
Secondary outcome [10] 0 0
High sensitivity CRP (hsCRP)
Timepoint [10] 0 0
Baseline - 24 weeks
Secondary outcome [11] 0 0
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Timepoint [11] 0 0
Baseline - 24 weeks
Secondary outcome [12] 0 0
Interleukin 6 (IL-6)
Timepoint [12] 0 0
Baseline - 24 weeks

Eligibility
Key inclusion criteria
Part A

1. = 40 to = 85 years of age, at the time of signing the informed consent.
2. Documented stable symptomatic HF (New York Heart Association Class II-IV) for at least 1 month at Screening (Visit 1) (transient HF in the setting of an MI does not qualify), with a medical history of typical symptoms of HF and receiving optimal therapy for HF as determined by the health-care physician.
3. LVEF > 40% at Screening (Visit 1). All participants will undergo a local echocardiogram at the Screening (Visit 1) with central reading to confirm the LVEF > 40% eligibility criteria before randomisation.
4. 6MWD = 30 meters and = 400 meters at Screening (Visit 1) and Randomisation (Visit 3). Difference in 6MWD between Screening and Randomisation must be < 50 meters.
5. KCCQ-TSS = 90 points at Screening (Visit 1) and Randomisation (Visit 3)
6. NT-proBNP = 250 pg/mL (sinus rhythm) or = 500 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI =30 kg/m2.

NT-proBNP = 200 pg/mL (sinus rhythm) or = 400 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI > 30 kg/m2.

The ECG performed at Screening should be used for heart rhythm evaluation.

7.At least one of the following:

1. Structural heart disease, ie, LA enlargement and/or left ventricular hypertrophy at the echocardiogram performed at Screening (Visit 1). Left atrial enlargement is defined by at least 1 of the following: LA width (diameter) = 3.8 cm or LA length = 5.0 cm, or LA area = 20 cm2 or LA volume = 55 mL or LAVI > 34 mL/m2. Left ventricular hypertrophy is defined by septal thickness or posterior wall thickness = 1.1 cm or LVMI > 95 g/m2 in women and > 115 g/m2 in men.
2. Spectral tissue Doppler echocardiography - E/e' ratio (average of septal and lateral) = 13 at rest at the echocardiogram performed at Screening (Visit 1).
3. Indirectly estimated elevation of PASP by TRmax velocity > 2.8 m/s (280 cm/s) (PASP > 35 mmHg) at the echocardiogram performed at Screening (Visit 1) OR directly measured pulmonary capillary wedge pressure > 15 mmHg at rest within the past 12 months or > 25 mmHg at exercise documented by right heart catheterisation within 12 months prior to Screening (Visit 1).
4. HF decompensation within 6 months before Randomisation (Visit 3), defined as hospitalisation for HF or IV diuretic treatment for HF during an urgent, unscheduled visit without hospitalisation.

8.Body mass index = 18.0 kg/m2 and = 45.0 kg/m2

9.Male or female of non-childbearing potential.

Part B
1. Participant must be = 40 to = 85 years of age, at the time of signing the informed consent.
2. Documented diagnosis of symptomatic HF (NYHA class II-IV) at Screening (Visit 1), and a medical history of typical symptoms/signs of heart failure = 6 weeks before Screening (Visit 1), and receiving optimal therapy for HF as determined by the health-care physician, with at least intermittent need for diuretic treatment.
3. LVEF >40% and evidence of structural heart disease (ie, left ventricular hypertrophy or

left atrial enlargement [defined by at least one of the following:LA enlargement and/or left ventricular hypertrophy at the echocardiogram

performed at Screening (Visit 1). Left atrial enlargement is defined by at least 1 of the following: LA width

(diameter) = 3.8 cm or LA length = 5.0 cm, or LA area = 20 cm2 or LA volume = 55 mL or LAVI > 34

mL/m2. Left ventricular hypertrophy is defined by septal thickness or posterior wall thickness = 1.1 cm or

LVMI > 95 g/m2 in women and > 115 g/m2 in men.]) documented by the most recent echocardiogram, or cardiac

magnetic resonance imaging within the last 12 months prior to Screening (Visit 1). If no

echocardiogram is available, it can be performed at Screening (Visit 1).
4. 6MWD = 30 meters and = 400 meters at Screening (Visit 1) and Randomisation (Visit 2). Difference in 6MWD between Screening and Randomisation must be < 50 meters
5. KCCQ-TSS = 90 points at Screening (Visit 1) and Randomisation (Visit 2).
6. NT-proBNP = 250 pg/mL (sinus rhythm) or = 500 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI = 30 kg/m2. NT-proBNP = 200 pg/mL (sinus rhythm) or = 400 pg/mL (atrial fibrillation/flutter) at Screening (Visit 1) for patients with BMI > 30 kg/m2. The ECG performed at Screening should be used for heart rhythm evaluation
7. Body mass index = 18.0 kg/m2 and = 45.0 kg/m2
8. Male or female of non-childbearing potential.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part A

1 eGFR < 30 mL/min/1.73m2 (Chronic Kidney Disease-Epidemiology Collaboration formula) at Screening (Visit 1).

2. Systolic blood pressure < 90 mmHg or = 160 mmHg if not on treatment with = 3 blood pressure lowering medications or = 180 mmHg irrespective of treatments at Randomisation

3. Heart rate > 110 bpm or < 50 bpm at Randomisation

4. Life expectancy < 3 years due to other reasons than cardiovascular disease.

5. History or ongoing allergy/hypersensitivity reactions to drugs (including but not limited to rash, angioedema, acute urticaria).

6. Presence of any disease or condition rather than HF constituting the main reason for limiting the ability to exercise/reduced exercise capacity.

7. Current decompensated HF and/or NT-proBNP > 5000 pg/mL at Screening (Visit 1)

8. Documented history of ejection fraction = 40%.i.e. HF with recovered ejection fraction. Transient ejection fraction decrease e.g. in the setting of an MI does not apply

9. Any planned cardiovascular procedure (eg, coronary revascularisation, ablation of atrial fibrillation/flutter, valve repair/replacement, aortic aneurysm surgery, etc).

10. Any cardiac event (eg, myocardial infarction, unstable angina), coronary revascularisation (percutaneous coronary intervention or coronary artery bypass grafting), ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronisation therapy device within 12 weeks prior to Screening (Visit 1) or between Screening and Randomisation. Patients who underwent a successful atrial fibrillation/flutter cardioversion, can be enrolled in the study after 4 weeks.

14. Hb < 110 g/L (male) and < 100 g/L (female) or iron-deficiency with/without anaemia requiring ongoing or planned IV iron treatment.

15. Participants with hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH =10 mIU/mL), or any clinically significant thyroid disease as judged by the investigator.

18. ALT or AST = 2 × ULN at Screening (Visit 1).

19. Pulmonary arterial hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (ie, requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory support within 12 months prior to Screening (Visit 1).

20. Any active infection requiring oral, intravenous or intramuscular treatment at Screening (Visit 1) and/or at Randomisation.

23 Any signs or confirmation of COVID-19 infection:
* Suspected (as judged by PI) or confirmed COVID-19 within the last 2 weeks prior to Screening (Visit 1) or at Randomisation.
* Hospitalisation for COVID-19 within the last 12 weeks prior to Screening (Visit 1).

24. Any concomitant medications known to be a potent CYP3A4 inducers or inhibitors, eg, itraconazole, rifampicin, clarithromycin, or propylthiouracil

29. Previous enrolment and randomisation in the present study. (Participants who where screened and screen failed and not randomised in Part A can be screened for possible entry to Part B).

All exclusion criteria in Part A are applicable to Part B with the following exceptions:

Exclusion criteria 4; 19

Exclusion Criteria specific for Part B only [criteria numeration for Part B]

4. Life expectancy < 2 years due to other reasons than cardiovascular disease.

11. HF due to any of the following: known infiltrative cardiomyopathy (eg, amyloid, sarcoid, lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), or uncorrected primary valvular disease.

18. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (ie, requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalization for exacerbation of COPD requiring ventilatory support within 12 months prior to Screening [Visit 1]).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/03/2024
Sample size
Target
Accrual to date
Final
711
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Frankston
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Florida
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Illinois
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Louisiana
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Maryland
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Missouri
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New York
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North Carolina
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Hasselt
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Huy
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TOURCOING cedex
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Kure-shi
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Nagano
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Naha
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Oita-shi
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Omihachiman-shi
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Otaru-shi
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Sagamihara-shi
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Toshima-ku
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Ueda-shi
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Uwajima-shi
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Yokohama-shi
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Netherlands
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Amsterdam
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Den Bosch
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Den Haag
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Deventer
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Heerlen
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Poland
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Bydgoszcz
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Lublin
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Rzeszow
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Skierniewice
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Tarnów
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Tczew
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Tychy
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Warszawa
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Poland
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Wolomin
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Russian Federation
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Aramil
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Perm
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Russian Federation
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St Petersburg
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Russian Federation
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Tver
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Brezno
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Slovakia
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Kosice
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Slovakia
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Nitra
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Slovakia
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Presov
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Sweden
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Göteborg
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Sweden
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Jönköping
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Sweden
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Lund
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Sweden
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Norrköping
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Sweden
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Stockholm
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Sweden
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Örebro
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei 112
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
State/province [131] 0 0
Eskisehir
Country [132] 0 0
Turkey
State/province [132] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04986202