Study identifier:D169CC00001
ClinicalTrials.gov identifier:NCT03619213
EudraCT identifier:2018-000802-46
CTIS identifier:N/A
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
Heart Failure with preserved Ejection Fraction
Phase 3
No
Dapagliflozin, Placebo
All
6263
Interventional
40 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2023 by AstraZeneca
AstraZeneca
-
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.
Location
Location
Taipei, Taiwan, Province of China, 11217
Location
Budapest, Hungary, 1122
Location
Benesov, Czech Republic, 256 01
Location
Groningen, Netherlands, 9700 RB
Location
Boston, MA, United States, 02115
Location
Novosibirsk, Russian Federation, 630055
Location
Ryazan, Russian Federation, 390039
Location
Saint-Petersburg, Russian Federation, 191015
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin Patients will be randomized 1:1 to either dapagliflozin or placebo. | Drug: Dapagliflozin 10 mg tablets given once daily, per oral use. Other Name: Forxiga TM Other Name: Farxiga TM |
Placebo Comparator: Placebo Placebo matching dapagliflozin. | Drug: Placebo Placebo matching dapagliflozin 10 mg |
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