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)
The study consists of a screening period (up to 2 weeks), a run-in period (4 weeks), a treatment period (8 weeks), and a follow-up period. During the study, all participants should continue their background antihypertensive medications (at the same agents and dosages as used within 4 weeks prior to screening) and maintain lifestyle interventions such as a low-salt diet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
382
For oral administration
For 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.
Time frame: Baseline and week 8
Change from baseline in SiSBP after 4 weeks of treatment
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
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.
Time frame: Baseline and week 4
Change from baseline in SiSDP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 8
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.
Time frame: Baseline and week 4
Change from baseline in ambulatory 24-hour average SDP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
Change from baseline in ambulatory 24-hour average SBP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo
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Time frame: Baseline and week 8
Change from baseline in ambulatory 24-hour average SDP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo
Time frame: Baseline and week 8
Change from baseline in ambulatory night-time average SBP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
Change from baseline in ambulatory night-time average SDP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
Change from baseline in ambulatory night-time average SBP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 8
Change from baseline in ambulatory night-time average SDP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 8
Change from baseline in ambulatory daytime average SBP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
Change from baseline in ambulatory daytime average SDP after 4 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 4
Change from baseline in ambulatory daytime average SBP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 8
Change from baseline in ambulatory daytime average SDP after 8 weeks of treatment.
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Time frame: Baseline and week 8
Number of Participants with Treatment Emergent Adverse Events (TEAEs).
AEs will be assessed using Mild/moderate/severe.
Time frame: Baseline up to approximately Week 10
Number of Participants with Serious Adverse Events (SAEs).
AEs will be assessed using Mild/moderate/severe.
Time frame: Baseline up to approximately Week 10