Aprocitentan tablets are currently the only endothelin dual receptor antagonist approved internationally for the treatment of resistant hypertension.This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of aprocitentan tablets(SYH9108) in patients with treatment-resistant hypertension (rHTN)
Male or female participants must be ≥18 years of age.
Participants must have received stable doses of ≥3 antihypertensive agents from distinct pharmacological classes for at least 4 weeks prior to signing the ICF, with such therapy maintained until randomization.
During the screening period and prior to randomization, SiSBP ≥140 mmHg with or without SiDBP ≥90 mmHg, and SiSBP <180 mmHg and SiDBP <110 mmHg.
Participants are able to understand and cooperate in completing this trial, voluntarily participate in the trial, and sign the Informed Consent Form (ICF).
Presence of secondary hypertension.
Have had transient ischemic attack, stroke, unstable angina pectoris, or acute myocardial infarction occurring within the period from 12 months prior to signing the ICF up to randomization.
From screening to prior to randomization, have presence of uncontrolled severe disease or life-threatening disease, or failure to recover from major surgery, or prior thyroid surgery, or presence of malignant tumor, or meeting the criteria for severe hepatic insufficiency at screening.
Have had unstable cardiac disease occurring within the period from 6 months prior to signing the ICF up to randomization.
Parallel
Aprocitentan tablets(SYH9108)
DrugFor oral administration
Placebo
DrugFor oral administration. The placebo is identical to aprocitentan tablets(SYH9108) in appearance.
Change from baseline in Sitting Systolic Blood Pressure (SiSBP) after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo on SiSBP at Week 8.
Change from baseline in SiSBP after 4 weeks of treatment
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Change from baseline in Sitting Diastolic Blood Pressure (SiSDP) after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Change from baseline in SiSDP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Change from baseline in ambulatory 24-hour average SBP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
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