Back to resultsDapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER)
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction
Eligibility Criteria
Inclusion Criteria:
- Provision of signed informed consent prior to any study specific procedures.
- Male or female patients age ≥40 years.
- Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
- Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
- Elevated NT-pro BNP levels.
- Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
Further details regarding inclusion criteria 4-6 may apply.
Exclusion Criteria:
- Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
- Type 1 diabetes mellitus (T1D).
- eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
- Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
- Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
- MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
- Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
- Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
- Body mass index >50 kg/m2.
Further exclusion criteria may apply
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dapagliflozin
Placebo
Arm Description
Patients will be randomized 1:1 to either dapagliflozin or placebo.
Placebo matching dapagliflozin.
Outcomes
Primary Outcome Measures
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
Dual primary efficacy
Primary endpoint analysed in all patients randomised (Full analysis set).
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation
Dual primary efficacy
Primary endpoint analysed in all patients randomised with LVEF < 60% at baseline.
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Secondary Outcome Measures
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)
Secondary efficacy
Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients.
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation
Secondary efficacy
Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF < 60% at baseline
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Change From Baseline in the KCCQ Total Symptom Score at 8 Months
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Subjects Included in the Endpoint of Cardiovascular Death
Secondary efficacy
The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Subjects Included in the Endpoint of All-cause Mortality
Secondary efficacy
The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03619213
Brief Title
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
Acronym
DELIVER
Official Title
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
March 27, 2022 (Actual)
Study Completion Date
March 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
Detailed Description
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
International, Double-blind, Randomised, Placebo-Controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Patients will be randomized 1:1 to either dapagliflozin or placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching dapagliflozin.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Forxiga TM, Farxiga TM
Intervention Description
10 mg tablets given once daily, per oral use.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching dapagliflozin 10 mg
Primary Outcome Measure Information:
Title
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
Description
Dual primary efficacy
Primary endpoint analysed in all patients randomised (Full analysis set).
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
Title
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation
Description
Dual primary efficacy
Primary endpoint analysed in all patients randomised with LVEF < 60% at baseline.
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
Secondary Outcome Measure Information:
Title
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)
Description
Secondary efficacy
Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients.
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
Title
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation
Description
Secondary efficacy
Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF < 60% at baseline
The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
Title
Change From Baseline in the KCCQ Total Symptom Score at 8 Months
Description
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame
Baseline and 8 months or death before 8 months
Title
Subjects Included in the Endpoint of Cardiovascular Death
Description
Secondary efficacy
The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
Title
Subjects Included in the Endpoint of All-cause Mortality
Description
Secondary efficacy
The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Time Frame
Up to 42.1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed informed consent prior to any study specific procedures.
Male or female patients age ≥40 years.
Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
Elevated NT-pro BNP levels.
Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
Further details regarding inclusion criteria 4-6 may apply.
Exclusion Criteria:
Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
Type 1 diabetes mellitus (T1D).
eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
Body mass index >50 kg/m2.
Further exclusion criteria may apply
Facility Information:
Facility Name
Research Site
City
Fairhope
State/Province
Alabama
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36532
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United States
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City
Mobile
State/Province
Alabama
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Sheffield
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Tucson
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Arizona
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Little Rock
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Loma Linda
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California
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Los Angeles
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Stamford
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Connecticut
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Clearwater
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Miami
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Naples
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Port Charlotte
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Saint Augustine
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Atlanta
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Chicago
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Chicago
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Gurnee
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Anderson
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Hammond
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Boston
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02114
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Bridgewater
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New York
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New York
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New York
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New York
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Charlotte
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Greensboro
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Altoona
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Doylestown
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Providence
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Charleston
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Rapid City
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Jackson
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Nashville
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Tullahoma
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Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Research Site
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Research Site
City
Catamarca
ZIP/Postal Code
K4700
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1407GTN
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5003
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5000AAW
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5003DCP
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5006CBI
Country
Argentina
Facility Name
Research Site
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Research Site
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Research Site
City
San Nicolás
ZIP/Postal Code
B2900DMH
Country
Argentina
Facility Name
Research Site
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Facility Name
Research Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Research Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Research Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-240
Country
Brazil
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30210-090
Country
Brazil
Facility Name
Research Site
City
Blumenau
ZIP/Postal Code
89020-430
Country
Brazil
Facility Name
Research Site
City
Campina Grande do Sul
ZIP/Postal Code
83430000
Country
Brazil
Facility Name
Research Site
City
Campinas
ZIP/Postal Code
13010-001
Country
Brazil
Facility Name
Research Site
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80230-130
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020090
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01141-020
Country
Brazil
Facility Name
Research Site
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Research Site
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Facility Name
Research Site
City
Haskovo
Country
Bulgaria
Facility Name
Research Site
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Research Site
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1700
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6W 2X7
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Z 4N5
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P6
Country
Canada
Facility Name
Research Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M6B 3H7
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Research Site
City
Port Perry
State/Province
Ontario
ZIP/Postal Code
L9L 1L1
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 1N1
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6G 1M2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6N 1B5
Country
Canada
Facility Name
Research Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2T 0C1
Country
Canada
Facility Name
Research Site
City
York
State/Province
Ontario
ZIP/Postal Code
M9N 1W4
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Research Site
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Research Site
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Research Site
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100049
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Research Site
City
Cangzhou
ZIP/Postal Code
061001
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130033
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chifeng
ZIP/Postal Code
024000
Country
China
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Research Site
City
Daqing
ZIP/Postal Code
163000
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350031
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510100
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Research Site
City
Haerbin
ZIP/Postal Code
150001
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
2100008
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210011
Country
China
Facility Name
Research Site
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110015
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300142
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300457
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430000
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430033
Country
China
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Research Site
City
Benesov
ZIP/Postal Code
256 01
Country
Czechia
Facility Name
Research Site
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
612 00
Country
Czechia
Facility Name
Research Site
City
Jaromer
ZIP/Postal Code
551 01
Country
Czechia
Facility Name
Research Site
City
Kladno
ZIP/Postal Code
272 80
Country
Czechia
Facility Name
Research Site
City
Louny
ZIP/Postal Code
440 01
Country
Czechia
Facility Name
Research Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Research Site
City
Ostrava-Dubina
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Research Site
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1171
Country
Hungary
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Research Site
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Research Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Adachi-ku
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
Research Site
City
Asahi-shi
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Research Site
City
Azumino-shi
ZIP/Postal Code
399-8292
Country
Japan
Facility Name
Research Site
City
Beppu-shi
ZIP/Postal Code
874-0011
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Research Site
City
Fujisawa-shi
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
Research Site
City
Fujisawa-shi
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Research Site
City
Funabashi-shi
ZIP/Postal Code
274-0065
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Research Site
City
Hamada-shi
ZIP/Postal Code
697-8511
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
430-0929
Country
Japan
Facility Name
Research Site
City
Higashiohmi-shi
ZIP/Postal Code
527-8505
Country
Japan
Facility Name
Research Site
City
Ichinomiya-shi
ZIP/Postal Code
494-0001
Country
Japan
Facility Name
Research Site
City
Iizuka-shi
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Research Site
City
Iwakuni-shi
ZIP/Postal Code
740-8510
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Research Site
City
Kasugai-shi
ZIP/Postal Code
487-0016
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Research Site
City
Kishiwada-shi
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
654-0155
Country
Japan
Facility Name
Research Site
City
Koga-shi
ZIP/Postal Code
306-0041
Country
Japan
Facility Name
Research Site
City
Kuki-shi
ZIP/Postal Code
346-0021
Country
Japan
Facility Name
Research Site
City
Kure-shi
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Research Site
City
Mito-shi
ZIP/Postal Code
311-4198
Country
Japan
Facility Name
Research Site
City
Miura-gun
ZIP/Postal Code
240-0116
Country
Japan
Facility Name
Research Site
City
Nakagami-gun
ZIP/Postal Code
901-2393
Country
Japan
Facility Name
Research Site
City
Nishinomiya-shi
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0855
Country
Japan
Facility Name
Research Site
City
Saga-shi
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Research Site
City
Sagamihara-shi
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
564-8565
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
ZIP/Postal Code
760-0018
Country
Japan
Facility Name
Research Site
City
Takasago-shi
ZIP/Postal Code
676-0812
Country
Japan
Facility Name
Research Site
City
Toride-shi
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-1101
Country
Japan
Facility Name
Research Site
City
Tsuchiura-shi
ZIP/Postal Code
300-0028
Country
Japan
Facility Name
Research Site
City
Ueda-shi
ZIP/Postal Code
386-8610
Country
Japan
Facility Name
Research Site
City
Ureshino-shi
ZIP/Postal Code
843-0393
Country
Japan
Facility Name
Research Site
City
Utsunomiya-shi
ZIP/Postal Code
320-8580
Country
Japan
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Culiacán
ZIP/Postal Code
80200
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44210
Country
Mexico
Facility Name
Research Site
City
Mazatlán
ZIP/Postal Code
82000
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Research Site
City
Monclova
ZIP/Postal Code
25750
Country
Mexico
Facility Name
Research Site
City
Monterey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Research Site
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Research Site
City
Tijuana
ZIP/Postal Code
22150
Country
Mexico
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Research Site
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Research Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Research Site
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Research Site
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Research Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Research Site
City
Leiderdorp
ZIP/Postal Code
2353 GA
Country
Netherlands
Facility Name
Research Site
City
Meppel
ZIP/Postal Code
7943 KA
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Research Site
City
Uden
ZIP/Postal Code
5406 PT
Country
Netherlands
Facility Name
Research Site
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Facility Name
Research Site
City
Callao
ZIP/Postal Code
CALLAO 2
Country
Peru
Facility Name
Research Site
City
Chancay
ZIP/Postal Code
15131
Country
Peru
Facility Name
Research Site
City
Chorrillos
ZIP/Postal Code
Lima 9
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
14
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L11
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L18
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Facility Name
Research Site
City
San Isidro
ZIP/Postal Code
15073
Country
Peru
Facility Name
Research Site
City
Urb. El Chipe
ZIP/Postal Code
20007
Country
Peru
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-111
Country
Poland
Facility Name
Research Site
City
Bochnia
ZIP/Postal Code
32-700
Country
Poland
Facility Name
Research Site
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-286
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
Research Site
City
Jasło
ZIP/Postal Code
38-200
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-056
Country
Poland
Facility Name
Research Site
City
Oława
ZIP/Postal Code
55-200
Country
Poland
Facility Name
Research Site
City
Płock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Wierzchosławice
ZIP/Postal Code
33-122
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700304
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700400
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700515
Country
Romania
Facility Name
Research Site
City
Tg Mures
ZIP/Postal Code
540143
Country
Romania
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454091
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614056
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Research Site
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Research Site
City
Dammam
ZIP/Postal Code
31463
Country
Saudi Arabia
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
21499
Country
Saudi Arabia
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
22252
Country
Saudi Arabia
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
11462
Country
Saudi Arabia
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
11525
Country
Saudi Arabia
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Hospitalet de Llobregat(Barcel
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Sanlúcar De Barrameda (Cádiz)
ZIP/Postal Code
11540
Country
Spain
Facility Name
Research Site
City
Santiago(A Coruña)
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Villamartín (Cádiz)
ZIP/Postal Code
11650
Country
Spain
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11220
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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
IPD Sharing 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
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
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Mc Causland FR, Claggett BL, Vaduganathan M, Desai AS, Jhund P, de Boer RA, Docherty K, Fang J, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Saraiva JFK, McGrath MM, Shah SJ, Verma S, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Dapagliflozin and Kidney Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):56-65. doi: 10.1001/jamacardio.2022.4210.
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PubMed Identifier
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Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Hegde SM, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Time to Clinical Benefit of Dapagliflozin in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2022 Dec 1;7(12):1259-1263. doi: 10.1001/jamacardio.2022.3750.
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Desai AS, Jhund PS, Claggett BL, Vaduganathan M, Miao ZM, Kondo T, Barkoudah E, Brahimi A, Connolly E, Finn P, Lang NN, Mc Causland FR, McGrath M, Petrie MC, McMurray JJV, Solomon SD. Effect of Dapagliflozin on Cause-Specific Mortality in Patients With Heart Failure Across the Spectrum of Ejection Fraction: A Participant-Level Pooled Analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2022 Dec 1;7(12):1227-1234. doi: 10.1001/jamacardio.2022.3736.
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PubMed Identifier
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Myhre PL, Vaduganathan M, Claggett BL, Miao ZM, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Influence of NT-proBNP on Efficacy of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JACC Heart Fail. 2022 Dec;10(12):902-913. doi: 10.1016/j.jchf.2022.08.007. Epub 2022 Aug 27.
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PubMed Identifier
36100197
Citation
Peters AE, Ogunniyi MO, Hegde SM, Bianco C, Ghafghazi S, Hernandez AF, DeVore AD. A multicenter program for electronic health record screening for patients with heart failure with preserved ejection fraction: Lessons from the DELIVER-EHR initiative. Contemp Clin Trials. 2022 Oct;121:106924. doi: 10.1016/j.cct.2022.106924. Epub 2022 Sep 12.
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36041912
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Cunningham JW, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, McGrath MM, O'Meara E, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Patients Recently Hospitalized With Heart Failure and Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Oct 4;80(14):1302-1310. doi: 10.1016/j.jacc.2022.07.021. Epub 2022 Aug 27.
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36041669
Citation
Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Estimated Long-Term Benefit of Dapagliflozin in Patients With Heart Failure. J Am Coll Cardiol. 2022 Nov 8;80(19):1775-1784. doi: 10.1016/j.jacc.2022.08.745. Epub 2022 Aug 27.
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36041668
Citation
Butt JH, Kondo T, Jhund PS, Comin-Colet J, de Boer RA, Desai AS, Hernandez AF, Inzucchi SE, Janssens SP, Kosiborod MN, Lam CSP, Langkilde AM, Lindholm D, Martinez F, Petersson M, Shah SJ, Thierer J, Vaduganathan M, Verma S, Wilderang U, Claggett BC, Solomon SD, McMurray JJV. Atrial Fibrillation and Dapagliflozin Efficacy in Patients With Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. 2022 Nov 1;80(18):1705-1717. doi: 10.1016/j.jacc.2022.08.718. Epub 2022 Aug 27.
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36029467
Citation
Peikert A, Martinez FA, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Shah SJ, Katova T, Merkely B, Vardeny O, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Efficacy and Safety of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Age: The DELIVER Trial. Circ Heart Fail. 2022 Oct;15(10):e010080. doi: 10.1161/CIRCHEARTFAILURE.122.010080. Epub 2022 Aug 27.
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Butt JH, Jhund PS, Belohlavek J, de Boer RA, Chiang CE, Desai AS, Drozdz J, Hernandez AF, Inzucchi SE, Katova T, Kitakaze M, Kosiborod MN, Lam CSP, Maria Langkilde A, Lindholm D, Bachus E, Martinez F, Merkely B, Petersson M, Saraiva JFK, Shah SJ, Vaduganathan M, Vardeny O, Wilderang U, Claggett BL, Solomon SD, McMurray JJV. Efficacy and Safety of Dapagliflozin According to Frailty in Patients With Heart Failure: A Prespecified Analysis of the DELIVER Trial. Circulation. 2022 Oct 18;146(16):1210-1224. doi: 10.1161/CIRCULATIONAHA.122.061754. Epub 2022 Aug 27.
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PubMed Identifier
36027570
Citation
Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.
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PubMed Identifier
35241246
Citation
Solomon SD, Vaduganathan M, Claggett BL, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Belohlavek J, Chiang CE, Willem Borleffs CJ, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Kerr Saraiva JF, Tereschenko SN, Thierer J, Vardeny O, Verma S, Vinh PN, Wilderang U, Zaozerska N, Lindholm D, Petersson M, McMurray JJV. Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial. JACC Heart Fail. 2022 Mar;10(3):184-197. doi: 10.1016/j.jchf.2021.11.006.
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Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
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Links:
URL
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Description
Redacted Clinical Study Protocol
URL
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Description
Redacted Statistical Analysis Plan
URL
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Description
Redacted CSR Synopsis
Learn more about this trial
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
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