Resistant HypertensionPhase 3NCT07635914
A Study Evaluating Aprocitentan Tablets(SYH9108) for the Treatment of Resistant Hypertension
A Phase 3 study testing Aprocitentan tablets(SYH9108) in people with Resistant Hypertension, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Aprocitentan tablets(SYH9108)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 31 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 15Show fewer
- 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:
- 1) 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.
- 14. 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Aprocitentan Tablets in the Treatment of Resistant Hypertension
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)
Read the detailed description
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.
- Conditions
- Resistant Hypertension
- Being tested
- Aprocitentan tablets(SYH9108), Placebo
- Keywords
- Resistant hypertension, rHTN, Aprocitentan, SYH9108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprocitentan tablets(SYH9108)Drug
For oral administration
PlaceboDrug
For oral administration. The placebo is identical to aprocitentan tablets(SYH9108) in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Aprocitentan tablets(SYH9108) | Experimental | Not described Receives: Drug: Aprocitentan tablets(SYH9108) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 8
Secondary outcomes (17)
Change from baseline in SiSBP after 4 weeks of treatment
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 8
Number of Participants with Treatment Emergent Adverse Events (TEAEs).
AEs will be assessed using Mild/moderate/severe.
Measured: Baseline up to approximately Week 10
Number of Participants with Serious Adverse Events (SAEs).
AEs will be assessed using Mild/moderate/severe.
Measured: Baseline up to approximately Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion28 Dec 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635914
- Sponsor's protocol ID
- SYH9108-002
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Aprocitentan Tablets in the Treatment of Resistant Hypertension
- ClinicalTrials.gov ID
- NCT07635914
- Acronym / sponsor ID
- SYH9108-002
- Conditions
- Resistant Hypertension
- Keywords
- Resistant hypertension, rHTN, Aprocitentan, SYH9108
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aprocitentan tablets(SYH9108) | Experimental | Drug: Aprocitentan tablets(SYH9108) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprocitentan tablets(SYH9108)For oral administration | Drug | Aprocitentan tablets(SYH9108) |
| PlaceboFor oral administration. The placebo is identical to aprocitentan tablets(SYH9108) in appearance. | Drug | Placebo |
Primary outcome
Change from baseline in Sitting Systolic Blood Pressure (SiSBP) after 8 weeks of treatment.
Time frame: Baseline and week 8
To assess the effect of treatment with Aprocitentan tablets(SYH9108) versus placebo on SiSBP at Week 8.
17 secondary outcomes
Change from baseline in SiSBP after 4 weeks of treatment
Time frame: Baseline and week 4
Change from baseline in Sitting Diastolic Blood Pressure (SiSDP) after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in SiSDP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory 24-hour average SBP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory 24-hour average SDP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory 24-hour average SBP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory 24-hour average SDP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory night-time average SBP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory night-time average SDP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory night-time average SBP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory night-time average SDP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory daytime average SBP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory daytime average SDP after 4 weeks of treatment.
Time frame: Baseline and week 4
Change from baseline in ambulatory daytime average SBP after 8 weeks of treatment.
Time frame: Baseline and week 8
Change from baseline in ambulatory daytime average SDP after 8 weeks of treatment.
Time frame: Baseline and week 8
Number of Participants with Treatment Emergent Adverse Events (TEAEs).
Time frame: Baseline up to approximately Week 10
Number of Participants with Serious Adverse Events (SAEs).
Time frame: Baseline up to approximately Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprocitentan tablets(SYH9108) in people with Resistant Hypertension, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (+86311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Sitting Systolic Blood Pressure (SiSBP) after 8 weeks of treatment. (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.