Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Prevent-HF
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
2 other identifiers
interventional
11,300
35 countries
942
Brief Summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Mar 2025
Longer than P75 for phase_3 heart-failure
942 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
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 6, 2024
CompletedStudy Start
First participant enrolled
March 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 17, 2029
May 18, 2026
May 1, 2026
4.8 years
November 5, 2024
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation * CV death
Event driven; Up to 38 months
Secondary Outcomes (5)
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality
Event driven; Up to 38 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF)
Event driven; Up to 38 months
Study Arms (2)
Baxdrostat/Dapagliflozin
EXPERIMENTALParticipants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Placebo/Dapagliflozin
EXPERIMENTALPatients will receive a dose of dapagliflozin in combination with matching placebo
Interventions
baxdrostat tablet and dapagliflozin tablet
Eligibility Criteria
You may qualify if:
- Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
- Diagnosed with T2DM and requiring treatment
- Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
- At least one additional risk factor for HF:
- Age ≥ 70 years
- UACR \> 20 mg/g
- eGFR \< 60 mL/min/1.73 m2
- History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
- History of atrial fibrillation or atrial flutter
- NT-proBNP \> 125 ng/L
You may not qualify if:
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR \< 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
- Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
- Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
- Percutaneous coronary intervention within 1 month prior to randomisation
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- Documented history of adrenal insufficiency
- Any dialysis (including for acute kidney injury) within 3 months prior to screening
- Any acute kidney injury within 3 months prior to screening
- Prohibited concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (942)
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Birmingham, Alabama, 35205, United States
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Centreville, Alabama, 35042, United States
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Fairhope, Alabama, 36532, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Sheffield, Alabama, 35660, United States
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Vestavia Hills, Alabama, 35216, United States
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Anchorage, Alaska, 99508, United States
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Gilbert, Arizona, 85296, United States
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Glendale, Arizona, 85308, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85712, United States
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Dublin, California, 94568, United States
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Huntington Beach, California, 92648, United States
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Inglewood, California, 90301, United States
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La Jolla, California, 92037, United States
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Lakewood, California, 90805, United States
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Lincoln, California, 95648, United States
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Loma Linda, California, 92357, United States
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Los Angeles, California, 90035, United States
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Los Angeles, California, 90073, United States
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Sacramento, California, 95841, United States
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San Diego, California, 92120, United States
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San Dimas, California, 91773, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94121, United States
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Santa Maria, California, 93454, United States
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Sherman Oaks, California, 91403, United States
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Thousand Oaks, California, 91360, United States
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Aurora, Colorado, 80012, United States
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Englewood, Colorado, 80110, United States
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Bridgeport, Connecticut, 06606, United States
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Stamford, Connecticut, 06905, United States
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Waterbury, Connecticut, 06708, United States
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Crystal River, Florida, 34429, United States
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Fort Lauderdale, Florida, 33316, United States
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Fort Myers, Florida, 33912, United States
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Gainesville, Florida, 32608, United States
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Hialeah, Florida, 33012, United States
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Jacksonville, Florida, 32216, United States
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Lakeland, Florida, 33813, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33173, United States
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Ocoee, Florida, 34761, United States
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Orlando, Florida, 32822, United States
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Palmetto Bay, Florida, 33157, United States
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Saint Augustine, Florida, 32086, United States
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Albany, Georgia, 31707, United States
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Atlanta, Georgia, 30303, United States
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Canton, Georgia, 30114, United States
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Columbus, Georgia, 31904, United States
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Cordele, Georgia, 31015, United States
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Suwanee, Georgia, 30024, United States
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Tucker, Georgia, 30084, United States
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Woodstock, Georgia, 30189, United States
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Idaho Falls, Idaho, 83404, United States
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Champaign, Illinois, 61822, United States
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Chicago, Illinois, 60616, United States
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Chicago, Illinois, 60621, United States
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Chicago, Illinois, 60631, United States
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Gurnee, Illinois, 60031, United States
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Island Lake, Illinois, 60042, United States
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Park Ridge, Illinois, 60068, United States
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Indianapolis, Indiana, 46202, United States
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Munster, Indiana, 46321, United States
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Richmond, Indiana, 47374, United States
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South Bend, Indiana, 46617, United States
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El Dorado, Kansas, 67042, United States
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Lenexa, Kansas, 66219, United States
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Newton, Kansas, 67114, United States
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Wichita, Kansas, 67218, United States
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Lexington, Kentucky, 40509, United States
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Owensboro, Kentucky, 42301, United States
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Paducah, Kentucky, 42001, United States
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Alexandria, Louisiana, 71303, United States
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Bossier City, Louisiana, 71111, United States
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Shreveport, Louisiana, 71101, United States
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Baltimore, Maryland, 21229, United States
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Beltsville, Maryland, 20705, United States
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Lutherville-Timonium, Maryland, 21093, United States
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Potomac, Maryland, 20854, United States
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Boston, Massachusetts, 02115, United States
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New Bedford, Massachusetts, 02740, United States
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Roslindale, Massachusetts, 02131, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48532, United States
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Troy, Michigan, 48098, United States
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Ypsilanti, Michigan, 48197, United States
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Mankato, Minnesota, 56001, United States
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Minneapolis, Minnesota, 55417, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64151, United States
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St Louis, Missouri, 63136, United States
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Kalispell, Montana, 59901, United States
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Missoula, Montana, 59804, United States
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Norfolk, Nebraska, 68701, United States
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Omaha, Nebraska, 68134, United States
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Carson City, Nevada, 89706, United States
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Portsmouth, New Hampshire, 03801, United States
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Eatontown, New Jersey, 07724, United States
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Pennington, New Jersey, 08534, United States
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Somerset, New Jersey, 08873, United States
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Albuquerque, New Mexico, 87102, United States
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Albuquerque, New Mexico, 87108, United States
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Albany, New York, 12208, United States
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Albany, New York, 12211, United States
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Brooklyn, New York, 11201, United States
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Brooklyn, New York, 11220, United States
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Massapequa, New York, 11758, United States
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New York, New York, 10029, United States
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Queens Village, New York, 11428, United States
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Charlotte, North Carolina, 28287, United States
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Durham, North Carolina, 27701, United States
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Fayetteville, North Carolina, 28304, United States
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Kernersville, North Carolina, 27284, United States
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Monroe, North Carolina, 28112, United States
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New Bern, North Carolina, 28562, United States
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Raleigh, North Carolina, 27607, United States
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Rocky Mount, North Carolina, 27804, United States
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Fargo, North Dakota, 58104, United States
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Beavercreek, Ohio, 45431, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43228, United States
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Dayton, Ohio, 45424, United States
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Maumee, Ohio, 43537, United States
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Toledo, Ohio, 43606, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73111, United States
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Oklahoma City, Oklahoma, 73120, United States
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Medford, Oregon, 97504, United States
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Camp Hill, Pennsylvania, 17011, United States
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Horsham, Pennsylvania, 19044, United States
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Philadelphia, Pennsylvania, 19114, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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West Chester, Pennsylvania, 19380, United States
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Columbia, South Carolina, 29209, United States
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Fort Mill, South Carolina, 29715, United States
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Greenville, South Carolina, 29615, United States
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Mt. Pleasant, South Carolina, 29464, United States
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North Charleston, South Carolina, 29405, United States
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Spartanburg, South Carolina, 29301, United States
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Cleveland, Tennessee, 37312, United States
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Morristown, Tennessee, 37813, United States
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Nashville, Tennessee, 37203, United States
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Abilene, Texas, 79606, United States
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Austin, Texas, 78704, United States
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Beaumont, Texas, 77702, United States
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Brownsville, Texas, 78526, United States
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Dallas, Texas, 75390-9015, United States
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Duncanville, Texas, 75137, United States
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El Paso, Texas, 79905, United States
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El Paso, Texas, 79935, United States
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Houston, Texas, 77084, United States
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Houston, Texas, 77089, United States
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Lewisville, Texas, 75067, United States
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Mansfield, Texas, 76063, United States
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McAllen, Texas, 78501, United States
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McAllen, Texas, 78503, United States
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Mesquite, Texas, 75149, United States
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Paris, Texas, 75462, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78231, United States
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San Antonio, Texas, 78257, United States
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Stephenville, Texas, 76401, United States
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Sugar Land, Texas, 77479, United States
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Tomball, Texas, 77375, United States
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Weslaco, Texas, 78596, United States
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Woodway, Texas, 76712, United States
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Clearfield, Utah, 84015, United States
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Ogden, Utah, 84405, United States
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Burlington, Vermont, 05401, United States
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Burke, Virginia, 22015, United States
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Charlottesville, Virginia, 22911, United States
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Fairfax, Virginia, 22033, United States
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Falls Church, Virginia, 22042, United States
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Manassas, Virginia, 20110, United States
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Midlothian, Virginia, 23112, United States
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Norfolk, Virginia, 23502, United States
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Norfolk, Virginia, 23504, United States
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Richmond, Virginia, 23249, United States
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Salem, Virginia, 24153, United States
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Puyallup, Washington, 98372, United States
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Redmond, Washington, 98052, United States
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Renton, Washington, 98057, United States
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Kingwood, West Virginia, 26537, United States
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Morgantown, West Virginia, 26505, United States
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Green Bay, Wisconsin, 54303, United States
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Milwaukee, Wisconsin, 53226, United States
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Buenos Aires, C1425AGC, Argentina
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CABA, C1056ABH, Argentina
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CABA, C1119ACN, Argentina
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CABA, C1120AAC, Argentina
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Caba, C1128AAF, Argentina
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Ciudad de Buenos Aires, C1428DCO, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5003DCP, Argentina
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La Plata, B1904, Argentina
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Mar del Plata, B7600FZN, Argentina
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Mar del Plata, B7600GNY, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000PBJ, Argentina
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San Nicolás, B2900DMH, Argentina
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San Nicolás de los Arroyos, B2900DPA, Argentina
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San Vicente, 5006, Argentina
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Santa Fe, S3000FWO, Argentina
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Adelaide, 5000, Australia
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Castle Hill, 2154, Australia
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Coffs Harbour, 02450, Australia
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Elizabeth Vale, 5112, Australia
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Fremantle, 6160, Australia
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Geelong, 3220, Australia
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Kingswood, 2747, Australia
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Leabrook, 5068, Australia
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Maroubra, 2035, Australia
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Merewether, 2291, Australia
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Milton, 4064, Australia
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Mulgrave, 3170, Australia
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Osborne Park, 6017, Australia
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Rockhampton, 4700, Australia
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Wollongong, 2500, Australia
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Belém, 66073-005, Brazil
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Blumenau, 89010-022, Brazil
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Bragança Paulista, 12916-542, Brazil
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Brasília, 71625-009, Brazil
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Campina Grande do Sul, 83.430-000, Brazil
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Campinas, 13060-080, Brazil
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Campinas, 13060-904, Brazil
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Curitiba, 80030-480, Brazil
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Curitiba, 80810-050, Brazil
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Juiz de Fora, 36033-318, Brazil
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Natal, 59020-035, Brazil
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Porto Alegre, 90160-093, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 90630-165, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20241-180, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São José dos Campos, 12230-001, Brazil
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São Paulo, 01228-000, Brazil
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São Paulo, 01236-030, Brazil
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São Paulo, 04012-180, Brazil
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São Paulo, 05403-000, Brazil
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Tatuí, 18270-170, Brazil
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Haskovo, 6300, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Pleven, 5804, Bulgaria
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Plovdiv, 4003, Bulgaria
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Rousse, 7000, Bulgaria
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Shumen, 9700, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1680, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Calgary, Alberta, T2H 2G4, Canada
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Calgary, Alberta, T2V 4J2, Canada
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Sherwood Park, Alberta, T8H 0N2, Canada
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Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
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Moncton, New Brunswick, E1C 2Z3, Canada
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Saint John, New Brunswick, E2L 4L2, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8J 0B6, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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Markham, Ontario, L3S 0A2, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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North York, Ontario, M6B 3H7, Canada
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North York, Ontario, M9N 1W4, Canada
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Oakville, Ontario, L6K 3W7, Canada
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Ottawa, Ontario, K2J 0V2, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Scarborough Village, Ontario, M1B 4Z8, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Laval, Quebec, H7T 2P5, Canada
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Lévis, Quebec, G6V 9H4, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H4A 3T2, Canada
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Québec, Quebec, G1G 5X1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Terrebonne, Quebec, J6X 4P7, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Regina, Saskatchewan, S4P 0W5, Canada
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Baotou, 14010, China
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Beijing, 100029, China
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Beijing, 100029, China
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Beijing, 100050, China
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Changchun, 130021, China
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Changchun, 130033, China
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Changde, 415000, China
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Changsha, 410011, China
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Changsha, 410015, China
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Changzhou, 272100, China
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Chengdu, 610000, China
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Chengdu, 610041, China
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Chifeng, 024000, China
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Chongqing, 400014, China
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Chongqing, 400042, China
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Guangzhou, 510100, China
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Guangzhou, 511486, China
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Harbin, 150000, China
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Hefei, 230001, China
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Hengyang, 421001, China
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Heze, 274099, China
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Huangshi, 435000, China
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Huizhou, 516002, China
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Jinan, 250001, China
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Jining, 272006, China
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Kaifeng, 475000, China
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Liaocheng, 252000, China
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Linhai, 317000, China
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Linyi, 276003, China
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Lishui, 323000, China
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Luoyang, 471000, China
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Luoyang, 471001, China
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Meihekou, 135022, China
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Nanchang, 330009, China
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Nanjing, 210008, China
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Nantong, 226001, China
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Nanyang, 473000, China
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Panjin, 124009, China
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Pingxiang, 337055, China
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Sanya, 572000, China
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Shanghai, 200240, China
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Shanghai, 201114, China
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Shenyang, 110016, China
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Siping, 136000, China
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Suzhou, 215004, China
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Taiyuan, 030024, China
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Tianjin, 300000, China
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Wenzhou, 325000, China
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Wuhan, 430010, China
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Wuhan, 430060, China
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Xi'an, 710061, China
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Xi'an, 710068, China
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Xianyang, 750004, China
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Xuzhou, 221009, China
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Yinchuan, 750004, China
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Zhumadian, 463000, China
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Zigong, 643000, China
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Benešov, 256 01, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Brno, 603 00, Czechia
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Brno, 639 00, Czechia
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Broumov, 55001, Czechia
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Chlumec nad Cidlinou, 503 51, Czechia
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Hodonín, 695 01, Czechia
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Humpolec, 396 01, Czechia
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Jílové u Prahy, 254 01, Czechia
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Krnov, 794 01, Czechia
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Olomouc, 772 00, Czechia
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Ostrava, 702 00, Czechia
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Pilsen, 301 00, Czechia
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Police nad Metují, 549 54, Czechia
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Prague, 101 00, Czechia
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Prague, 104 00, Czechia
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Prague, 12808, Czechia
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Prague, 149 00, Czechia
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Prague, 150 00, Czechia
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Prague, 190 14, Czechia
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Aarhus, 8200, Denmark
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Aarhus N, 8200, Denmark
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Copenhagen, 2300, Denmark
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Esbjerg, 6700, Denmark
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Frederiksberg, 2000, Denmark
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Gistrup, 9260, Denmark
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Herlev, 2730, Denmark
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Herning, 7400, Denmark
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Hillerød, 3400, Denmark
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Hjørring, 9800, Denmark
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Holbæk, 4300, Denmark
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Hvidovre, 2650, Denmark
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Roskilde, 4000, Denmark
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Slagelse, DK-4200, Denmark
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Svendborg, 5700, Denmark
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Angeles City, 2009, Philippines
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Bialystok, 15-481, Poland
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Bacau, 600274, Romania
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Weston-super-Mare, BS24 7PR, United Kingdom
Research Site
Wolverhampton, WV10 0QP, United Kingdom
Research Site
Woodbridge, IP136TH, United Kingdom
Research Site
Yate, BS37 4AX, United Kingdom
Research Site
Can Tho, 900000, Vietnam
Research Site
Haiphong, 180000, Vietnam
Research Site
Hanoi, 10000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Research Site
Huế, 530000, Vietnam
Research Site
Rach Gia, 920000, Vietnam
Research Site
Vĩnh Yên, 280000, Vietnam
Related Publications (1)
Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
PMID: 40913594DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo controlled
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2024
First Posted
November 6, 2024
Study Start
March 14, 2025
Primary Completion (Estimated)
December 17, 2029
Study Completion (Estimated)
December 17, 2029
Last Updated
May 18, 2026
Record last verified: 2026-05
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/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.