A Study Evaluating Aprocitentan Tablets(SYH9108) for the Treatment of Resistant Hypertension

NCT07635914 | Not Yet Recruiting Phase 3

• 1 other identifier: SYH9108-002
• Study Type: interventional
• Target: 382
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Resistant Hypertension

Keywords

Resistant hypertension; rHTN; Aprocitentan; SYH9108

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 8

Secondary Outcomes (17)

• Change from baseline in SiSBP after 4 weeks of treatment

  Baseline and week 4

• Change from baseline in Sitting Diastolic Blood Pressure (SiSDP) after 4 weeks of treatment.

  Baseline and week 4

• Change from baseline in SiSDP after 8 weeks of treatment.

  Baseline and week 8

• Change from baseline in ambulatory 24-hour average SBP after 4 weeks of treatment.

  Baseline and week 4

• Change from baseline in ambulatory 24-hour average SDP after 4 weeks of treatment.

  Baseline and week 4

Study Arms (2)

Aprocitentan tablets(SYH9108)

EXPERIMENTAL

Drug: Aprocitentan tablets(SYH9108)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aprocitentan tablets(SYH9108) DRUG

For oral administration

Aprocitentan tablets(SYH9108)

Placebo DRUG

For oral administration. The placebo is identical to aprocitentan tablets(SYH9108) in appearance.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Have received dialysis at any time prior to signing the ICF or prior to randomization.
• Type 1 diabetes.
• Compliance with any background antihypertensive drug or placebo is \<80% or \>120% during the run-in period.
• Use of endothelin receptor antagonists, antihypertensive drugs other than background medications, or other blood pressure-affecting drugs, or high-dose loop diuretics from 4 weeks prior to signing the ICF until randomization; or use of oligonucleotide antihypertensive agents within 1 year prior to signing the ICF.
• Hypersensitivity or suspected hypersensitivity to the excipients of the investigational product, endothelin receptor antagonists, or background antihypertensive drugs, or potential hypersensitivity to the investigational product.
• Participated in other clinical trials and received at least one dose of study treatment within 12 weeks prior to signing the ICF.
• Average night shifts are ≥ 2 times per week during the 4 weeks prior to signing the ICF, the screening period, the run-in period, or the anticipated study period.
• History of drug abuse or alcohol abuse within 5 years prior to signing the ICF.
• Any of the following test results during the screening period or prior to randomization:
• \) BMI≥37.5 kg/m2. 2) Hemoglobin \< 100 g/L; 3) NT-proBNP ≥ 500 pg/mL; 4) QTcF: \> 450 ms in males, \> 470 ms in females; 5) eGFR \< 15 mL/min/1.73 m²; 6) ALT or AST \> 3 × ULN, or total bilirubin \> 1.5 × ULN; 7) HbA1c \> 8.0%; 8) TSH outside the normal range and FT3 and/or FT4 outside the normal range; 9) Positive HBsAg and positive HBV-DNA, or positive for any of anti-HCV antibody, anti-HIV antibody, anti-Treponema pallidum antibody.
• \. Female participants of childbearing potential who are pregnant, breastfeeding, or have a positive pregnancy test from signing the ICF until randomization; or female participants of childbearing potential and male participants who plan to conceive (including sperm or egg donation) and/or are unable to use effective contraceptive methods during the study period and within 30 days after the end of treatment.

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 9, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share