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
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
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.
Inclusion Criteria:
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:
Exclusion Criteria:
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CABA, C1056ABH, Argentina
CABA, C1119ACN, Argentina
CABA, C1120AAC, Argentina
Caba, C1128AAF, Argentina
Ciudad de Buenos Aires, C1428DCO, Argentina
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Nyíregyháza-Sóstóhegy, 4481, Hungary
Herzelia, 4640200, Israel
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Diepkloof, Soweto, 2013, South Africa
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