Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06307652
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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.
Interventions
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balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
(Drug)
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
-
balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
(Drug)
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
-
dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
(Drug)
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Eligibility criteria
Conditions
Locations
- Research Site — Alexander City, Alabama, United States
- Research Site — Birmingham, Alabama, United States
- Research Site — Fairhope, Alabama, United States
- Research Site — Huntsville, Alabama, United States
- Research Site — Phoenix, Arizona, United States
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- Research Site — Rzeszów, Poland
- Research Site — Rzeszów, Poland
- Research Site — Szczecin, Poland
- Research Site — Tarnów, Poland
- Research Site — Torun, Poland
- Research Site — Tychy, Poland
- Research Site — Warsaw, Poland
- Research Site — Warsaw, Poland
- Research Site — Warsaw, Poland
- Research Site — Wroclaw, Poland
- Research Site — Wroclaw, Poland
- Research Site — Zabrze, Poland
- Research Site — Afumaţi, Romania
- Research Site — Arad, Romania
- Research Site — Baia Mare, Romania
- Research Site — Brasov, Romania
- Research Site — Brasov, Romania
- Research Site — Bucharest, Romania
- Research Site — Bucharest, Romania
- Research Site — Bucharest, Romania
- Research Site — Bucharest, Romania
- Research Site — Bucharest, Romania
- Research Site — Cluj-Napoca, Romania
- Research Site — Iași, Romania
- Research Site — Iași, Romania
- Research Site — Satu Mare, Romania
- Research Site — Târgu Mureş, Romania
- Research Site — Târgu Mureş, Romania
- Research Site — Timișoara, Romania
- Research Site — Timișoara, Romania
- Research Site — Dammam, Saudi Arabia
- Research Site — Jeddah, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Banská Bystrica, Slovakia
- Research Site — Bratislava, Slovakia
- Research Site — Bratislava, Slovakia
- Research Site — Brezno, Slovakia
- Research Site — Košice, Slovakia
- Research Site — Košice, Slovakia
- Research Site — Martin, Slovakia
- Research Site — Myjava, Slovakia
- Research Site — Nitra, Slovakia
- Research Site — Nové Zámky, Slovakia
- Research Site — Považská Bystrica, Slovakia
- Research Site — Prešov, Slovakia
- Research Site — Rimavská Sobota, Slovakia
- Research Site — Svidník, Slovakia
- Research Site — Bloemfontein, South Africa
- Research Site — Centurion, South Africa
- Research Site — Durban, South Africa
- Research Site — Johannesburg, South Africa
- Research Site — KwaDukuza, South Africa
- Research Site — Panorama, South Africa
- Research Site — Parow, South Africa
- Research Site — Pietermaritzburg, South Africa
- Research Site — Somerset West, South Africa
- Research Site — Soweto, South Africa
- Research Site — Worcester, South Africa
- Research Site — Anyang-si, South Korea
- Research Site — Bucheon-si, South Korea
- Research Site — Busan, South Korea
- Research Site — Busan, South Korea
- Research Site — Busan, South Korea
- Research Site — Busan, South Korea
- Research Site — Cheongju-si, South Korea
- Research Site — Daegu, South Korea
- Research Site — Daejeon, South Korea
- Research Site — Gwangju, South Korea
- Research Site — Gwangmyeong, South Korea
- Research Site — Incheon, South Korea
- Research Site — Junggu, South Korea
- Research Site — Seongnam-si, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Seoul, South Korea
- Research Site — Uijeongbu-si, South Korea
- Research Site — Wŏnju, South Korea
- Research Site — Yangsan, South Korea
- Research Site — A Coruña, Spain
- Research Site — Barcelona, Spain
- Research Site — Barcelona, Spain
- Research Site — Barcelona, Spain
- Research Site — Lugo, Spain
- Research Site — Madrid, Spain
- Research Site — Madrid, Spain
- Research Site — Majadahonda, Spain
- Research Site — Seville, Spain
- Research Site — Seville, Spain
- Research Site — Seville, Spain
- Research Site — Valencia, Spain
- Research Site — Alingsås, Sweden
- Research Site — Gothenburg, Sweden
- Research Site — Jönköping, Sweden
- Research Site — Karlstad, Sweden
- Research Site — Mölndal, Sweden
- Research Site — Stockholm, Sweden
- Research Site — Stockholm, Sweden
- Research Site — Stockholm, Sweden
- Research Site — Stockholm, Sweden
- Research Site — Uppsala, Sweden
- Research Site — Västerås, Sweden
- Research Site — Changhua, Taiwan
- Research Site — Kaohsiung City, Taiwan
- Research Site — Kaohsiung City, Taiwan
- Research Site — New Taipei City, Taiwan
- Research Site — New Taipei City, Taiwan
- Research Site — New Taipei City, Taiwan
- Research Site — Taichung, Taiwan
- Research Site — Taichung, Taiwan
- Research Site — Taichung, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taipei, Taiwan
- Research Site — Taoyuan, Taiwan
- Research Site — Yilan, Taiwan
- Research Site — Yung Kang City, Taiwan
- Research Site — Bangkok, Thailand
- Research Site — Bangkok, Thailand
- Research Site — Bangkok, Thailand
- Research Site — Chiang Mai, Thailand
- Research Site — Hat Yai, Thailand
- Research Site — Khon Kaen, Thailand
- Research Site — Naimuang, Thailand
- Research Site — Pathum Thani, Thailand
- Research Site — Adana, Turkey (Türkiye)
- Research Site — Ankara, Turkey (Türkiye)
- Research Site — Antalya, Turkey (Türkiye)
- Research Site — Antalya, Turkey (Türkiye)
- Research Site — Bursa, Turkey (Türkiye)
- Research Site — Center, Turkey (Türkiye)
- Research Site — Dinar, Turkey (Türkiye)
- Research Site — Eskişehir, Turkey (Türkiye)
- Research Site — Istanbul, Turkey (Türkiye)
- Research Site — Izmir, Turkey (Türkiye)
- Research Site — Kocaeli, Turkey (Türkiye)
- Research Site — Kütahya, Turkey (Türkiye)
- Research Site — Muğla, Turkey (Türkiye)
- Research Site — Sivas, Turkey (Türkiye)
- Research Site — Chernivtsі, Ukraine
- Research Site — Ivano-Frankivsk, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Kyiv, Ukraine
- Research Site — Ternopil, Ukraine
- Research Site — Ternopil, Ukraine
- Research Site — Uzhhorod, Ukraine
- Research Site — Vinnytsia, Ukraine
- Research Site — Vinnytsia, Ukraine
- Research Site — Zhytomyr, Ukraine
- Research Site — Airdrie, United Kingdom
- Research Site — Barnet, United Kingdom
- Research Site — Cambridge, United Kingdom
- Research Site — Clydebank, United Kingdom
- Research Site — Exeter, United Kingdom
- Research Site — Harefield, United Kingdom
- Research Site — Hastings, United Kingdom
- Research Site — High Wycombe, United Kingdom
- Research Site — Kent, United Kingdom
- Research Site — Kings Lynn, United Kingdom
- Research Site — Lincoln, United Kingdom
- Research Site — London, United Kingdom
- Research Site — London, United Kingdom
- Research Site — Middlesbrough, United Kingdom
- Research Site — Portsmouth, United Kingdom
- Research Site — Sheffield, United Kingdom
- Research Site — Sunderland, United Kingdom
- Research Site — Wakefield, United Kingdom
- Research Site — Can Tho, Vietnam
- Research Site — Da Nang, Vietnam
- Research Site — Haiphong, Vietnam
- Research Site — Hanoi, Vietnam
- Research Site — Hà Nội, Vietnam
- Research Site — Ho Chi Minh City, Vietnam
- Research Site — Ho Chi Minh City, Vietnam
- Research Site — Hochiminh City, Vietnam
- Research Site — Hochiminh, Vietnam
- Research Site — Hồ Chí Minh, Vietnam
- Research Site — Huế, Vietnam
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