This new study is part of the phase III clinical program of firibastat with the objective of demonstrating the long-term safety of the product as well as its efficacy at 3 months, after a single daily dose of 1000 mg.
'We are very happy to be able to launch this pivotal study now with the new dosage form in a once-daily tablet, which will immediately put on the market a form better suited to chronic treatment ', declared
This multicenter, multinational study will recruit 750 patients with difficult-to-treat or resistant high blood pressure, in
During a first 3-month randomized double-blind period, 750 patients will receive either firibastat (1000 mg once a day) or a placebo, in addition to their current treatment. The primary endpoint will be the reduction in systolic blood pressure measured automatically in the doctor's office (AOBP) from the baseline. This period will be followed by a phase aimed at verifying the safety of the product over a period of 6 months up to 12 months for 100 patients, mandatory data for the registration of chronic treatment.
The selection of clinical centers will begin and the regulatory files (ethics committees and competent authorities) are being prepared for each country. The recruitment of the first patient will be carried out in the second quarter of 2021 and the efficacy and safety results at 6 months are expected by mid-2023, allowing the filing of marketing authorization applications in 2023. The cost of this The study was budgeted and will be funded through partnerships with
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