Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
BalanceD-HF
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
2 other identifiers
interventional
4,800
38 countries
834
Brief Summary
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Typical duration for phase_3
834 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
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
April 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2027
April 27, 2026
April 1, 2026
3.2 years
February 6, 2024
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation
Approximately 38 months
Secondary Outcomes (5)
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Approximately 38 months
Total occurrences (first and recurrent) of HF hospitalisations
Approximately 38 months
Time to CV death
Approximately 38 months
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24-week post-randomisation
Approximately 24 weeks
Time to death from any cause
Approximately 38 months
Study Arms (3)
balcinrenone/dapagliflozin 15 mg/10 mg
EXPERIMENTALPatients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
balcinrenone/dapagliflozin 40 mg/10 mg
EXPERIMENTALPatients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
dapagliflozin 10 mg
ACTIVE COMPARATORPatients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Interventions
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- Having had a recent HF event within 6 months (hospitalization or urgent visit)
- Have a LVEF value from an assessment within the last 12 months
- Managed with SoC therapy for HF and renal impairment according to local guidelines
- NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
- Not taking an MRA
- An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
- Serum/plasma potassium ≤ 5.0 mmol/L
You may not qualify if:
- Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
- Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
- History of hypertrophic obstructive cardiomyopathy
- Complex congenital heart disease or severe uncorrected primary valvular disease
- Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
- Type 1 diabetes mellitus
- Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
- Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- Treatment with strong or moderate CYP3A4 inhibitor or inducer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (845)
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Alexander City, Alabama, 35010, United States
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Birmingham, Alabama, 35209, United States
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Fairhope, Alabama, 36532, United States
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Huntsville, Alabama, 35801, United States
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Phoenix, Arizona, 85016, United States
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Phoenix, Arizona, 85044, United States
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Little Rock, Arkansas, 72205, United States
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Beverly Hills, California, 90211, United States
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Covina, California, 91723, United States
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Encinitas, California, 92024, United States
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Los Angeles, California, 90073, United States
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Los Angeles, California, 90089, United States
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Newport Beach, California, 92663, United States
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Orange, California, 92868, United States
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Redding, California, 96001, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94110, United States
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San Francisco, California, 94121, United States
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Santa Ana, California, 92704, United States
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Thousand Oaks, California, 91360, United States
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Vista, California, 92081, United States
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West Hills, California, 91307, United States
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Aurora, Colorado, 80045, United States
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Wheat Ridge, Colorado, 80033, United States
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Altamonte Springs, Florida, 32701, United States
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Boca Raton, Florida, 33486, United States
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Bradenton, Florida, 34209, United States
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Clearwater, Florida, 33756, United States
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Delray Beach, Florida, 33484, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32209, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33176, United States
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Miami Lakes, Florida, 33014, United States
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Palm Beach Gardens, Florida, 33410, United States
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Pensacola, Florida, 32503, United States
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Port Charlotte, Florida, 33952, United States
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Safety Harbor, Florida, 34695, United States
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Saint Augustine, Florida, 32086, United States
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St. Petersburg, Florida, 33701, United States
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Tampa, Florida, 33617, United States
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Atlanta, Georgia, 30303, United States
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Atlanta, Georgia, 30309, United States
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Peachtree City, Georgia, 30269, United States
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Thomasville, Georgia, 31792, United States
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Tucker, Georgia, 30084, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Glenview, Illinois, 60026, United States
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Hazel Crest, Illinois, 60429, United States
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North Chicago, Illinois, 60064, United States
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Peoria, Illinois, 61614, United States
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Winfield, Illinois, 60190, United States
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Elkhart, Indiana, 46514, United States
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Evansville, Indiana, 47710, United States
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Hammond, Indiana, 46324, United States
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Indianapolis, Indiana, 46237, United States
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Muncie, Indiana, 47303, United States
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Munster, Indiana, 46321, United States
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Richmond, Indiana, 47374, United States
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Waterloo, Iowa, 50701, United States
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Wichita, Kansas, 67218, United States
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Wichita, Kansas, 67226, United States
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Louisville, Kentucky, 40202, United States
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Alexandria, Louisiana, 71301, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71105, United States
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West Monroe, Louisiana, 71291, United States
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Augusta, Maine, 04330, United States
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Rockville, Maryland, 20850, United States
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Boston, Massachusetts, 02114, United States
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Fall River, Massachusetts, 02721, United States
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Worcester, Massachusetts, 01655, United States
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Ann Arbor, Michigan, 48109, United States
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Bloomfield Hills, Michigan, 48304, United States
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Dearborn, Michigan, 48126, United States
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Farmington Hills, Michigan, 48334, United States
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Flint, Michigan, 48504, United States
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Troy, Michigan, 48098, United States
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Ypsilanti, Michigan, 48197, United States
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Minneapolis, Minnesota, 55455, United States
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Saint Paul, Minnesota, 55109, United States
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Jackson, Mississippi, 39216, 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, 64128, United States
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Lincoln, Nebraska, 68506, United States
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Lincoln, Nebraska, 68510, United States
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Henderson, Nevada, 89074, United States
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North Las Vegas, Nevada, 89086, United States
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Bridgewater, New Jersey, 08807, United States
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Jersey City, New Jersey, 07302, United States
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Somerset, New Jersey, 08873, United States
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Albany, New York, 12208, United States
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Brooklyn, New York, 11219, United States
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Brooklyn, New York, 11220, United States
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Clifton Park, New York, 12065, United States
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Manhasset, New York, 11030, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10029, United States
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Staten Island, New York, 10310, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10451, United States
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The Bronx, New York, 10455, United States
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Asheville, North Carolina, 28801, United States
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Chapel Hill, North Carolina, 27517, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27405, United States
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Pinehurst, North Carolina, 28374, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, 28401, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Dayton, Ohio, 45414, United States
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Maumee, Ohio, 43537, United States
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Springfield, Ohio, 45504, United States
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Oklahoma City, Oklahoma, 73102, United States
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Portland, Oregon, 97225, United States
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Abington, Pennsylvania, 19001, United States
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Camp Hill, Pennsylvania, 17011, United States
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Hershey, Pennsylvania, 17033, United States
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Horsham, Pennsylvania, 19044, United States
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Philadelphia, Pennsylvania, 19104, United States
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Providence, Rhode Island, 02908, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29401, United States
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Charleston, South Carolina, 29425, United States
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Ladson, South Carolina, 29456, United States
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Lancaster, South Carolina, 29720, United States
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Rapid City, South Dakota, 57701, United States
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Jackson, Tennessee, 38305, United States
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Knoxville, Tennessee, 37916, United States
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Memphis, Tennessee, 38120, United States
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Memphis, Tennessee, 38128, United States
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Nashville, Tennessee, 37212, United States
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Tullahoma, Tennessee, 37388, United States
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Allen, Texas, 75013, United States
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Amarillo, Texas, 79106, United States
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Amarillo, Texas, 79121, United States
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Cypress, Texas, 77429, United States
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Dallas, Texas, 75204, United States
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Dallas, Texas, 75216, United States
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Dallas, Texas, 75390, United States
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El Paso, Texas, 79905, United States
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Houston, Texas, 77002, United States
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Houston, Texas, 77025, United States
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Katy, Texas, 77493, United States
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Mansfield, Texas, 76063, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, 75071, United States
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Odessa, Texas, 79761, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78229, United States
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Sherman, Texas, 75092, United States
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Temple, Texas, 76508, United States
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Tyler, Texas, 75701, United States
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Tyler, Texas, 75702, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84148, United States
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Falls Church, Virginia, 22042, United States
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Newport News, Virginia, 23606, United States
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Puyallup, Washington, 98372, United States
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Seattle, Washington, 98101, United States
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Tacoma, Washington, 98405, United States
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Buenos Aires, 1416, Argentina
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Buenos Aires, C1056ABJ, Argentina
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Buenos Aires, C1180AAX, Argentina
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CABA, C1425AGC, Argentina
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Ciudad de Buenos Aires, 1425DES, Argentina
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Ciudad de Buenos Aires, C1419AHL, Argentina
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Corrientes, W3400CDS, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, X5006CBI, Argentina
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Esperanza, S3080BQU, Argentina
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Granadero Baigorria, S2152BOF, Argentina
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Mar del Plata, B7600GNY, Argentina
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Rosario, 2123, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, T4000ICL, Argentina
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Santa Fe, S3000FWO, Argentina
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Blacktown, 2148, Australia
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Cairns, 4870, Australia
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Canberra, 2605, Australia
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Chermside, 4032, Australia
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Clayton, 3168, Australia
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Concord, 2139, Australia
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Frankston, 3199, Australia
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Geelong, 3220, Australia
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Murdoch, WA6150, Australia
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North Tamworth, 2340, Australia
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Westmead, 2145, Australia
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Bad Ischl, 4820, Austria
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Braunau am Inn, 5280, Austria
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Graz, 8036, Austria
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Linz, 4020, Austria
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Saint Stefan/Stainz, 8511, Austria
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Salzburg, 5020, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1090, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Vöcklabruck, 4840, Austria
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Aracaju, 49015-380, Brazil
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Blumenau, 89020-430, Brazil
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Brasília, 70200-730, 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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Curitiba, 80730-150, Brazil
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Goiânia, 74605-020, Brazil
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Niterói, 24033-900, Brazil
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Porto Alegre, 90035-903, Brazil
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Rio Branco, 69915-030, Brazil
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Rio de Janeiro, 20241-180, Brazil
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Rio de Janeiro, 20551-030, Brazil
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Rio de Janeiro, 22061-080, Brazil
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São José dos Campos, 12230-001, Brazil
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São Paulo, 04012-180, Brazil
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São Paulo, 05403-000, Brazil
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Teresina, 64049-550, Brazil
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Uberlândia, 38400-500, Brazil
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Botevgrad, 2140, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Kozloduy, 3320, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4003, Bulgaria
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Sliven, 8800, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1756, Bulgaria
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Stara Zagora, 6000, Bulgaria
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New Westminster, British Columbia, V3L 3W4, Canada
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North Vancouver, British Columbia, V7M 2H4, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Cambridge, Ontario, N1R 7R1, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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London, Ontario, N6A 5A5, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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North York, Ontario, M6B 3H7, Canada
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Oakville, Ontario, L6K 3W7, Canada
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Oshawa, Ontario, L1J 2K1, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Peterborough, Ontario, K9J 0B2, Canada
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Thunder Bay, Ontario, P7B 7C7, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Antofagasta, 1240000, Chile
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Punta Arenas, 6200000, Chile
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Region Metropolitana, 7550000, Chile
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San Bernardo, 8070996, Chile
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Santiago, 7500587, Chile
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Santiago, 7500922, Chile
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Santiago, 7770086, Chile
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Santiago, 8330034, Chile
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Santiago, 8380453, Chile
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Santiago, 8910259, Chile
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Talcahuano, 4270918, Chile
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Temuco, 4781156, Chile
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Temuco, 4810345, Chile
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Valdivia, 5110683, Chile
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Victoria, 4720097, Chile
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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, 100034, China
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Beijing, 100037, China
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Beijing, 100730, China
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Changchun, 130033, China
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Changsha, 410015, China
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Changsha, 430033, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chifeng, 024000, China
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Chongqing, 404197, China
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Guangzhou, 510100, China
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Guangzhou, 510515, China
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Guangzhou, 510630, China
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Hangzhou, 310014, China
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Harbin, 150001, China
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Hengyang, 421001, China
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Heze, 274099, China
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Hohhot, 010017, China
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Jinan, 250013, China
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Jining, 272029, China
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Lanzhou, 730030, China
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Liaocheng, 252000, China
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Linhai, 317000, China
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Nanchang, 330009, China
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Nanchong, 637900, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanjing, 210029, China
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Ningbo, 315040, China
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Pingxiang, 337055, China
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Quzhou, 342000, China
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Sanya, 572000, China
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Shanghai, 200025, China
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Shanghai, 200062, China
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Shenyang, 110004, China
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Shenzhen, 518053, China
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Ürümqi, CN-830004, China
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Wuhan, 430022, China
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Wuhan, 430030, 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, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Zhangjiakou, 075061, China
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Zunyi, 563100, China
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Armenia, 630004, Colombia
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Barranquilla, 080020, Colombia
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Barranquilla, 80007, Colombia
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Bogotá, 110221, Colombia
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Bogotá, 111211, Colombia
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Cali, 760032, Colombia
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Cali, 760036, Colombia
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Manizales, 170004, Colombia
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Medellín, 050030, Colombia
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Medellín, 050034, Colombia
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Piedecuesta, 681017, Colombia
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Rionegro, 054047, Colombia
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Brno, 60200, Czechia
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Brno, 639 00, Czechia
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Broumov, 55001, Czechia
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Česká Lípa, 470 77, Czechia
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Jaroměř, 551 01, Czechia
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Louny, 440 01, Czechia
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Ostrava, 702 00, Czechia
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Ostrava, 702 00, Czechia
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Pilsen, 31001, Czechia
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Plzen - Bory, 305 99, Czechia
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Prague, 120 00, Czechia
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Přerov, 75152, Czechia
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Slaný, 274 01, Czechia
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Svitavy, 568 02, Czechia
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Ustí Nad Labem, 40011, Czechia
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Ústí nad Labem, 400 01, Czechia
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Zlín, 760 01, Czechia
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Helsinki, 00290, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Béziers, 34500, France
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Bron, 69667, France
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Caen, 14033, France
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Cholet, 49300, France
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Créteil, 94010, France
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Dijon, 21079, France
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La Roche-sur-Yon, 85925, France
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La Tronche, 38043, France
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Le Coudray, 28630, France
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Limoges, 87000, France
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Meaux, 77104, France
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Montauban, 82017, France
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Montpellier, 34000, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Orléans, 45100, France
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Paris, 75010, France
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Paris, 75015, France
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Poitiers, 86021, France
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Reims, 51092, France
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Rennes, 35033, France
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Rouen, 76031, France
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Saint-Quentin, 02100, France
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Strasbourg, 67091, France
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Toulon, 83100, France
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Toulouse, 31059, France
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Tours, 37044, France
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Valenciennes, 59300, France
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Bad Nauheim, 61231, Germany
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Bechhofen, 66894, Germany
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Berlin, 12203, Germany
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Berlin, 13405, Germany
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Bernau bei Berlin, 16321, Germany
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Chemnitz, 9113, Germany
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Coburg, 96450, Germany
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Dresden, 01099, Germany
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Dresden, 1307, Germany
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Elsterwerda, 04910, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Goslar, 38642, Germany
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Göttingen, 37075, Germany
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Hagen, 58135, Germany
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Hamburg, 20246, Germany
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Hamburg, 22457, Germany
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Hamburg, 22459, Germany
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Heidelberg, 69120, Germany
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Kaiserslautern, 67655, Germany
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Related Publications (1)
Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, Boca SM, Yang Y, Heijer M, Housler G, Leonsson-Zachrisson M, Hartleib-Geschwindner J, Pizzato PE. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone. Br J Clin Pharmacol. 2025 Jul;91(7):1937-1946. doi: 10.1002/bcp.70017. Epub 2025 Feb 17.
PMID: 39962632DERIVED
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
March 13, 2024
Study Start
April 12, 2024
Primary Completion (Estimated)
June 11, 2027
Study Completion (Estimated)
June 11, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
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.