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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06307652




Registration number
NCT06307652
Ethics application status
Date submitted
6/02/2024
Date registered
13/03/2024

Titles & IDs
Public title
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Scientific title
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
Secondary ID [1] 0 0
2023-508162-15-00
Secondary ID [2] 0 0
D6402C00012
Universal Trial Number (UTN)
Trial acronym
BalanceD-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure and Impaired Kidney Function 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
Treatment: Drugs - dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Experimental: balcinrenone/dapagliflozin 15 mg/10 mg - Patients 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

Experimental: balcinrenone/dapagliflozin 40 mg/10 mg - Patients 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

Active comparator: dapagliflozin 10 mg - Patients 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


Treatment: Drugs: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Treatment: Drugs: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Treatment: Drugs: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Timepoint [1] 0 0
Approximately 38 months
Secondary outcome [1] 0 0
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Timepoint [1] 0 0
Approximately 38 months
Secondary outcome [2] 0 0
Total occurrences (first and recurrent) of HF hospitalisations
Timepoint [2] 0 0
Approximately 38 months
Secondary outcome [3] 0 0
Time to CV death
Timepoint [3] 0 0
Approximately 38 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Approximately 24 weeks
Secondary outcome [5] 0 0
Time to death from any cause
Timepoint [5] 0 0
Approximately 38 months

Eligibility
Key inclusion criteria
* 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 = 3.5 mmol/L and = 5.0 mmol/L
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
* 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 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 < 100 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
* Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/06/2027
Actual
Sample size
Target
4800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Cairns
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Research Site - Concord
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Research Site - Frankston
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Research Site - Geelong
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Research Site - Murdoch
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2148 - Blacktown
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4870 - Cairns
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2605 - Canberra
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4032 - Chermside
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3168 - Clayton
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2139 - Concord
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3199 - Frankston
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3220 - Geelong
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WA6150 - Murdoch
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Country [204] 0 0
Hungary
State/province [204] 0 0
Hódmezovásárhely
Country [205] 0 0
Hungary
State/province [205] 0 0
Kecskemét
Country [206] 0 0
Hungary
State/province [206] 0 0
Orosháza
Country [207] 0 0
Hungary
State/province [207] 0 0
Pécs
Country [208] 0 0
Hungary
State/province [208] 0 0
Székesfehérvár
Country [209] 0 0
India
State/province [209] 0 0
Ahmedabad
Country [210] 0 0
India
State/province [210] 0 0
Ajmer
Country [211] 0 0
India
State/province [211] 0 0
Bangalore
Country [212] 0 0
India
State/province [212] 0 0
Belagavi
Country [213] 0 0
India
State/province [213] 0 0
Delhi
Country [214] 0 0
India
State/province [214] 0 0
Hyderabad
Country [215] 0 0
India
State/province [215] 0 0
Kanpur
Country [216] 0 0
India
State/province [216] 0 0
Karamsad
Country [217] 0 0
India
State/province [217] 0 0
Kolkata
Country [218] 0 0
India
State/province [218] 0 0
Manipal
Country [219] 0 0
India
State/province [219] 0 0
Mysuru
Country [220] 0 0
India
State/province [220] 0 0
Nagpur
Country [221] 0 0
India
State/province [221] 0 0
New Delhi
Country [222] 0 0
India
State/province [222] 0 0
Pune
Country [223] 0 0
India
State/province [223] 0 0
Vijayawada
Country [224] 0 0
Israel
State/province [224] 0 0
Afula
Country [225] 0 0
Israel
State/province [225] 0 0
Ashkelon
Country [226] 0 0
Israel
State/province [226] 0 0
Be'er Ya'akov
Country [227] 0 0
Israel
State/province [227] 0 0
Beer Sheva
Country [228] 0 0
Israel
State/province [228] 0 0
Haifa
Country [229] 0 0
Israel
State/province [229] 0 0
Holon
Country [230] 0 0
Israel
State/province [230] 0 0
Jerusalem
Country [231] 0 0
Israel
State/province [231] 0 0
Kfar-Saba
Country [232] 0 0
Israel
State/province [232] 0 0
Nahariya
Country [233] 0 0
Israel
State/province [233] 0 0
Petah Tikva
Country [234] 0 0
Israel
State/province [234] 0 0
Tel Aviv
Country [235] 0 0
Israel
State/province [235] 0 0
Tiberias
Country [236] 0 0
Italy
State/province [236] 0 0
Acquaviva delle Fonti
Country [237] 0 0
Italy
State/province [237] 0 0
Bari
Country [238] 0 0
Italy
State/province [238] 0 0
Bergamo
Country [239] 0 0
Italy
State/province [239] 0 0
Brescia
Country [240] 0 0
Italy
State/province [240] 0 0
Catanzaro
Country [241] 0 0
Italy
State/province [241] 0 0
Cona
Country [242] 0 0
Italy
State/province [242] 0 0
Cortona
Country [243] 0 0
Italy
State/province [243] 0 0
Firenze
Country [244] 0 0
Italy
State/province [244] 0 0
Milan
Country [245] 0 0
Italy
State/province [245] 0 0
Novara
Country [246] 0 0
Italy
State/province [246] 0 0
Pavia
Country [247] 0 0
Italy
State/province [247] 0 0
San Giovanni Rotondo
Country [248] 0 0
Japan
State/province [248] 0 0
Bunkyo-ku
Country [249] 0 0
Japan
State/province [249] 0 0
Fujisawa-shi
Country [250] 0 0
Japan
State/province [250] 0 0
Fukui-shi
Country [251] 0 0
Japan
State/province [251] 0 0
Fukuoka-Shi
Country [252] 0 0
Japan
State/province [252] 0 0
Fukuoka-shi
Country [253] 0 0
Japan
State/province [253] 0 0
Fukutsu-shi
Country [254] 0 0
Japan
State/province [254] 0 0
Hakusan-shi
Country [255] 0 0
Japan
State/province [255] 0 0
Himeji
Country [256] 0 0
Japan
State/province [256] 0 0
Iwakuni-shi
Country [257] 0 0
Japan
State/province [257] 0 0
Kanazawa-shi
Country [258] 0 0
Japan
State/province [258] 0 0
Kanonji-shi
Country [259] 0 0
Japan
State/province [259] 0 0
Kasuga-shi
Country [260] 0 0
Japan
State/province [260] 0 0
Kasugai-shi
Country [261] 0 0
Japan
State/province [261] 0 0
Kawaguchi
Country [262] 0 0
Japan
State/province [262] 0 0
Kawanishi-shi
Country [263] 0 0
Japan
State/province [263] 0 0
Kishiwada-shi
Country [264] 0 0
Japan
State/province [264] 0 0
Kitakyusyu-shi
Country [265] 0 0
Japan
State/province [265] 0 0
Kobe-shi
Country [266] 0 0
Japan
State/province [266] 0 0
Kochi-shi
Country [267] 0 0
Japan
State/province [267] 0 0
Maebashi-shi
Country [268] 0 0
Japan
State/province [268] 0 0
Matsumoto-shi
Country [269] 0 0
Japan
State/province [269] 0 0
Mito-shi
Country [270] 0 0
Japan
State/province [270] 0 0
Moriyama-shi
Country [271] 0 0
Japan
State/province [271] 0 0
Nagoya-shi
Country [272] 0 0
Japan
State/province [272] 0 0
Oita-shi
Country [273] 0 0
Japan
State/province [273] 0 0
Osaka-shi
Country [274] 0 0
Japan
State/province [274] 0 0
Sagamihara-shi
Country [275] 0 0
Japan
State/province [275] 0 0
Saitama shi
Country [276] 0 0
Japan
State/province [276] 0 0
Saitama-shi
Country [277] 0 0
Japan
State/province [277] 0 0
Sakai-shi
Country [278] 0 0
Japan
State/province [278] 0 0
Sakata City
Country [279] 0 0
Japan
State/province [279] 0 0
Sanyoonoda-shi
Country [280] 0 0
Japan
State/province [280] 0 0
Toshima-ku
Country [281] 0 0
Japan
State/province [281] 0 0
Toyota City
Country [282] 0 0
Japan
State/province [282] 0 0
Tsuchiura-shi
Country [283] 0 0
Japan
State/province [283] 0 0
Ueda-shi
Country [284] 0 0
Japan
State/province [284] 0 0
Uji-shi
Country [285] 0 0
Japan
State/province [285] 0 0
Uwajima-shi
Country [286] 0 0
Japan
State/province [286] 0 0
Yanagawa-shi
Country [287] 0 0
Japan
State/province [287] 0 0
Yokohama-shi
Country [288] 0 0
Korea, Republic of
State/province [288] 0 0
Busan
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Gwangju
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Incheon
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Seongnam-si
Country [292] 0 0
Korea, Republic of
State/province [292] 0 0
Seoul
Country [293] 0 0
Korea, Republic of
State/province [293] 0 0
Wonju-si
Country [294] 0 0
Korea, Republic of
State/province [294] 0 0
Yangsan-si
Country [295] 0 0
Malaysia
State/province [295] 0 0
Kajang
Country [296] 0 0
Malaysia
State/province [296] 0 0
Kota Kinabalu
Country [297] 0 0
Malaysia
State/province [297] 0 0
Kota Samarahan
Country [298] 0 0
Malaysia
State/province [298] 0 0
Kuala Lumpur
Country [299] 0 0
Malaysia
State/province [299] 0 0
Kuala Terengganu
Country [300] 0 0
Malaysia
State/province [300] 0 0
Kuantan
Country [301] 0 0
Malaysia
State/province [301] 0 0
Sungai Buloh
Country [302] 0 0
Mexico
State/province [302] 0 0
Aguascalientes
Country [303] 0 0
Mexico
State/province [303] 0 0
Chihuahua
Country [304] 0 0
Mexico
State/province [304] 0 0
Cuauhtémoc
Country [305] 0 0
Mexico
State/province [305] 0 0
Culiacan
Country [306] 0 0
Mexico
State/province [306] 0 0
Culiacán
Country [307] 0 0
Mexico
State/province [307] 0 0
Guadalajara
Country [308] 0 0
Mexico
State/province [308] 0 0
Mazatlán
Country [309] 0 0
Mexico
State/province [309] 0 0
Metepec
Country [310] 0 0
Mexico
State/province [310] 0 0
Mexico City
Country [311] 0 0
Mexico
State/province [311] 0 0
Mexico
Country [312] 0 0
Mexico
State/province [312] 0 0
Monterey
Country [313] 0 0
Mexico
State/province [313] 0 0
Morelia
Country [314] 0 0
Mexico
State/province [314] 0 0
México
Country [315] 0 0
Mexico
State/province [315] 0 0
Querétaro
Country [316] 0 0
Mexico
State/province [316] 0 0
San Luis Potosí
Country [317] 0 0
Mexico
State/province [317] 0 0
Tijuana
Country [318] 0 0
Mexico
State/province [318] 0 0
Torreon
Country [319] 0 0
Mexico
State/province [319] 0 0
Veracruz
Country [320] 0 0
Mexico
State/province [320] 0 0
Xalapa
Country [321] 0 0
Netherlands
State/province [321] 0 0
Amsterdam
Country [322] 0 0
Netherlands
State/province [322] 0 0
Arnhem
Country [323] 0 0
Netherlands
State/province [323] 0 0
Emmen
Country [324] 0 0
Netherlands
State/province [324] 0 0
Goes
Country [325] 0 0
Netherlands
State/province [325] 0 0
Groningen
Country [326] 0 0
Netherlands
State/province [326] 0 0
Hardenberg
Country [327] 0 0
Peru
State/province [327] 0 0
Bellavista
Country [328] 0 0
Peru
State/province [328] 0 0
Lima
Country [329] 0 0
Peru
State/province [329] 0 0
Piura
Country [330] 0 0
Philippines
State/province [330] 0 0
Angeles City
Country [331] 0 0
Philippines
State/province [331] 0 0
Cebu City
Country [332] 0 0
Philippines
State/province [332] 0 0
Davao City
Country [333] 0 0
Philippines
State/province [333] 0 0
Iloilo City
Country [334] 0 0
Philippines
State/province [334] 0 0
Las Pinas City
Country [335] 0 0
Philippines
State/province [335] 0 0
Mabalacat
Country [336] 0 0
Philippines
State/province [336] 0 0
Makati
Country [337] 0 0
Philippines
State/province [337] 0 0
Manadaluyong City
Country [338] 0 0
Philippines
State/province [338] 0 0
Manila
Country [339] 0 0
Philippines
State/province [339] 0 0
Marikina
Country [340] 0 0
Philippines
State/province [340] 0 0
Pasig City
Country [341] 0 0
Philippines
State/province [341] 0 0
Quezon City
Country [342] 0 0
Philippines
State/province [342] 0 0
Roxas City
Country [343] 0 0
Philippines
State/province [343] 0 0
Taguig City
Country [344] 0 0
Philippines
State/province [344] 0 0
West San Juan City
Country [345] 0 0
Poland
State/province [345] 0 0
Biala Podlaska
Country [346] 0 0
Poland
State/province [346] 0 0
Bielsko-Biala
Country [347] 0 0
Poland
State/province [347] 0 0
Bydgoszcz
Country [348] 0 0
Poland
State/province [348] 0 0
Chrzanów
Country [349] 0 0
Poland
State/province [349] 0 0
Gdynia
Country [350] 0 0
Poland
State/province [350] 0 0
Kazimierza Wielka
Country [351] 0 0
Poland
State/province [351] 0 0
Kraków
Country [352] 0 0
Poland
State/province [352] 0 0
Kedzierzyn-Kozle
Country [353] 0 0
Poland
State/province [353] 0 0
Lublin
Country [354] 0 0
Poland
State/province [354] 0 0
Olsztyn
Country [355] 0 0
Poland
State/province [355] 0 0
Ostrów Mazowiecka
Country [356] 0 0
Poland
State/province [356] 0 0
Piekary Slaskie
Country [357] 0 0
Poland
State/province [357] 0 0
Poznan
Country [358] 0 0
Poland
State/province [358] 0 0
Rzeszow
Country [359] 0 0
Poland
State/province [359] 0 0
Rzeszów
Country [360] 0 0
Poland
State/province [360] 0 0
Szczecin
Country [361] 0 0
Poland
State/province [361] 0 0
Tarnów
Country [362] 0 0
Poland
State/province [362] 0 0
Torun
Country [363] 0 0
Poland
State/province [363] 0 0
Tychy
Country [364] 0 0
Poland
State/province [364] 0 0
Warszawa
Country [365] 0 0
Poland
State/province [365] 0 0
Wroclaw
Country [366] 0 0
Poland
State/province [366] 0 0
Zabrze
Country [367] 0 0
Poland
State/province [367] 0 0
Lódz
Country [368] 0 0
Romania
State/province [368] 0 0
Bucharest
Country [369] 0 0
Romania
State/province [369] 0 0
Bucuresti
Country [370] 0 0
Romania
State/province [370] 0 0
Cluj-Napoca
Country [371] 0 0
Romania
State/province [371] 0 0
Iasi
Country [372] 0 0
Romania
State/province [372] 0 0
Targu Mures
Country [373] 0 0
Romania
State/province [373] 0 0
Timisoara
Country [374] 0 0
Romania
State/province [374] 0 0
Timi?oara
Country [375] 0 0
Saudi Arabia
State/province [375] 0 0
Ar Riya?
Country [376] 0 0
Saudi Arabia
State/province [376] 0 0
Dammam
Country [377] 0 0
Saudi Arabia
State/province [377] 0 0
Jeddah
Country [378] 0 0
Saudi Arabia
State/province [378] 0 0
Riyadh
Country [379] 0 0
Slovakia
State/province [379] 0 0
Banska Bystrica
Country [380] 0 0
Slovakia
State/province [380] 0 0
Bratislava
Country [381] 0 0
Slovakia
State/province [381] 0 0
Brezno
Country [382] 0 0
Slovakia
State/province [382] 0 0
Kosice
Country [383] 0 0
Slovakia
State/province [383] 0 0
Martin
Country [384] 0 0
Slovakia
State/province [384] 0 0
Myjava
Country [385] 0 0
Slovakia
State/province [385] 0 0
Nitra
Country [386] 0 0
Slovakia
State/province [386] 0 0
Nove Zamky
Country [387] 0 0
Slovakia
State/province [387] 0 0
Považská Bystrica
Country [388] 0 0
Slovakia
State/province [388] 0 0
Presov
Country [389] 0 0
Slovakia
State/province [389] 0 0
Prešov
Country [390] 0 0
Slovakia
State/province [390] 0 0
Rimavska Sobota
Country [391] 0 0
Slovakia
State/province [391] 0 0
Svidník
Country [392] 0 0
South Africa
State/province [392] 0 0
Bloemfontein
Country [393] 0 0
South Africa
State/province [393] 0 0
Centurion
Country [394] 0 0
South Africa
State/province [394] 0 0
Durban
Country [395] 0 0
South Africa
State/province [395] 0 0
Panorama
Country [396] 0 0
South Africa
State/province [396] 0 0
Parow
Country [397] 0 0
South Africa
State/province [397] 0 0
Somerset West
Country [398] 0 0
South Africa
State/province [398] 0 0
Worcester
Country [399] 0 0
Spain
State/province [399] 0 0
A Coruña
Country [400] 0 0
Spain
State/province [400] 0 0
Barcelona
Country [401] 0 0
Spain
State/province [401] 0 0
Lugo
Country [402] 0 0
Spain
State/province [402] 0 0
Madrid
Country [403] 0 0
Spain
State/province [403] 0 0
Majadahonda
Country [404] 0 0
Spain
State/province [404] 0 0
Sevilla
Country [405] 0 0
Sweden
State/province [405] 0 0
Alingsås
Country [406] 0 0
Sweden
State/province [406] 0 0
Göteborg
Country [407] 0 0
Sweden
State/province [407] 0 0
Helsingborg
Country [408] 0 0
Sweden
State/province [408] 0 0
Jonkoping
Country [409] 0 0
Sweden
State/province [409] 0 0
Karlstad
Country [410] 0 0
Sweden
State/province [410] 0 0
Lund
Country [411] 0 0
Sweden
State/province [411] 0 0
Molndal
Country [412] 0 0
Sweden
State/province [412] 0 0
Stockholm
Country [413] 0 0
Sweden
State/province [413] 0 0
Uppsala
Country [414] 0 0
Sweden
State/province [414] 0 0
Vasteras
Country [415] 0 0
Taiwan
State/province [415] 0 0
Changhua
Country [416] 0 0
Taiwan
State/province [416] 0 0
Kaohsiung
Country [417] 0 0
Taiwan
State/province [417] 0 0
New Taipei City
Country [418] 0 0
Taiwan
State/province [418] 0 0
New Taipei
Country [419] 0 0
Taiwan
State/province [419] 0 0
Taichung
Country [420] 0 0
Taiwan
State/province [420] 0 0
Taipei City
Country [421] 0 0
Taiwan
State/province [421] 0 0
Taipei
Country [422] 0 0
Taiwan
State/province [422] 0 0
Taoyuan
Country [423] 0 0
Taiwan
State/province [423] 0 0
Yilan
Country [424] 0 0
Taiwan
State/province [424] 0 0
Yung Kang City
Country [425] 0 0
Thailand
State/province [425] 0 0
Bangkok
Country [426] 0 0
Thailand
State/province [426] 0 0
Chiang Mai
Country [427] 0 0
Thailand
State/province [427] 0 0
Hat Yai
Country [428] 0 0
Thailand
State/province [428] 0 0
Khon Kaen
Country [429] 0 0
Thailand
State/province [429] 0 0
Naimuang
Country [430] 0 0
Thailand
State/province [430] 0 0
Pathumthani
Country [431] 0 0
Turkey
State/province [431] 0 0
Adana
Country [432] 0 0
Turkey
State/province [432] 0 0
Ankara
Country [433] 0 0
Turkey
State/province [433] 0 0
Antalya
Country [434] 0 0
Turkey
State/province [434] 0 0
Bursa
Country [435] 0 0
Turkey
State/province [435] 0 0
Dinar
Country [436] 0 0
Turkey
State/province [436] 0 0
Eskisehir
Country [437] 0 0
Turkey
State/province [437] 0 0
Istanbul
Country [438] 0 0
Turkey
State/province [438] 0 0
Izmir
Country [439] 0 0
Turkey
State/province [439] 0 0
Kocaeli
Country [440] 0 0
Turkey
State/province [440] 0 0
Kütahya
Country [441] 0 0
Turkey
State/province [441] 0 0
Merkez
Country [442] 0 0
Turkey
State/province [442] 0 0
Mugla
Country [443] 0 0
Turkey
State/province [443] 0 0
Sivas
Country [444] 0 0
Ukraine
State/province [444] 0 0
Chernivts?
Country [445] 0 0
Ukraine
State/province [445] 0 0
Ivano-Frankivsk
Country [446] 0 0
Ukraine
State/province [446] 0 0
Kyiv
Country [447] 0 0
Ukraine
State/province [447] 0 0
Ternopil
Country [448] 0 0
Ukraine
State/province [448] 0 0
Uzhhorod
Country [449] 0 0
Ukraine
State/province [449] 0 0
Vinnytsia
Country [450] 0 0
Ukraine
State/province [450] 0 0
Zhytomyr
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Airdrie
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Barnet
Country [453] 0 0
United Kingdom
State/province [453] 0 0
Cambridge
Country [454] 0 0
United Kingdom
State/province [454] 0 0
Clydebank
Country [455] 0 0
United Kingdom
State/province [455] 0 0
Exeter
Country [456] 0 0
United Kingdom
State/province [456] 0 0
Harefield
Country [457] 0 0
United Kingdom
State/province [457] 0 0
Hastings
Country [458] 0 0
United Kingdom
State/province [458] 0 0
High Wycombe
Country [459] 0 0
United Kingdom
State/province [459] 0 0
Kent
Country [460] 0 0
United Kingdom
State/province [460] 0 0
King's Lynn
Country [461] 0 0
United Kingdom
State/province [461] 0 0
Lincoln
Country [462] 0 0
United Kingdom
State/province [462] 0 0
London
Country [463] 0 0
United Kingdom
State/province [463] 0 0
Middlesborough
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Portsmouth
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Sheffield
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Sunderland
Country [467] 0 0
United Kingdom
State/province [467] 0 0
Wakefield
Country [468] 0 0
Vietnam
State/province [468] 0 0
Can Tho
Country [469] 0 0
Vietnam
State/province [469] 0 0
Da Nang
Country [470] 0 0
Vietnam
State/province [470] 0 0
Ha Noi
Country [471] 0 0
Vietnam
State/province [471] 0 0
Hai Phong
Country [472] 0 0
Vietnam
State/province [472] 0 0
Hanoi
Country [473] 0 0
Vietnam
State/province [473] 0 0
Ho Chi Minh city
Country [474] 0 0
Vietnam
State/province [474] 0 0
Ho Chi Minh City
Country [475] 0 0
Vietnam
State/province [475] 0 0
Ho Chi Minh
Country [476] 0 0
Vietnam
State/province [476] 0 0
Hochiminh city
Country [477] 0 0
Vietnam
State/province [477] 0 0
Hochiminh
Country [478] 0 0
Vietnam
State/province [478] 0 0
Hue

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the 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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06307652