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Not yet recruitingNCT07911735Updated Nov 4, 2026

A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients

A Phase 2 interventional study of SYH2072 Tablets and SYH2072 Tablets in Uncontrolled Hypertension and Resistant Hypertension, sponsored by InnovStone Therapeutics Limited. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by InnovStone Therapeutics Limited (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Title changedNewly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

SYH2072 is a highly selective aldosterone synthase inhibitor. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of SYH2072 tablets in patients with uncontrolled hypertension (including patients with resistant hypertension) receiving stable treatment with two or more antihypertensive agents.

02

Conditions studied

  • Uncontrolled Hypertension
  • Resistant Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 264 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

InnovStone Therapeutics Limited is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily participate in this study and sign the form.
  2. Age ≥ 18 years at the time of screening, male or female.
  3. Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and \<180 mmHg.
  4. During the run-in period, adherence to baseline antihypertensive medications and study medications ranged from 80% to 120% (including the boundary values);
  5. There were no changes in the types or doses of baseline antihypertensive medications prior to randomization, and no rescue therapy was administered.

Exclusion criteria

Exclusion Criteria:

  1. Known causes of secondary hypertension: renal artery stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic coarctation, etc.;
  2. Allergic constitution (allergies to ≥3 types/classes of drugs or foods); or known allergy to aldosterone synthase inhibitors or background antihypertensive medications;
  3. History of within the past 5 years, or a potential malignancy currently under evaluation;
  4. Type 2 diabetes with poor glycemic control, unstable antidiabetic treatment regimens within 4 weeks prior to screening, or type 1 diabetes;
  5. Hyperthyroidism or hypothyroidism requiring immediate treatment or medication adjustment; or subclinical hypothyroidism with a TSH level >10.0 mIU at screening or requiring medication as assessed by the investigator;
  6. Severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
  7. Individuals who plan to conceive (including through sperm or egg donation) from the signing of the ICF until 3 months after the last dose of the drug, and/or who do not agree to use effective non-pharmacological ;
  8. Pregnant or breastfeeding women.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    Low-dose group

    SYH2072 Tablets

    Drug: SYH2072 Tablets

  • Experimental
    Middle-dose group

    SYH2072 Tablets

    Drug: SYH2072 Tablets · Drug: placebo

  • Experimental
    High-dose group

    SYH2072 Tablets

    Drug: SYH2072 Tablets

  • Placebo comparator
    Placebo group

    Placebo

    Drug: placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change in mean seated systolic blood pressure (msSBP)

    Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment

    Time frame: at week 12

07

Study locations

No study locations are listed for this record.

08

Updates

2 registry updates since Sep 25, 2026
Title
A Phase Ⅱ Clinical TrialStudy Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Nov 4, 2026
Registered
First appeared on the registry
Nov 3, 2026
Show all 2 updates
  1. Nov 4, 2026
    Title A Phase Ⅱ Clinical TrialStudy Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
  2. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07911735
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Dec 13, 2026 (estimated)
Primary completion
Jul 22, 2027 (estimated)
Completion
Nov 28, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Clinical Trials Information Group NA officer
Contact
ctr-contact@cspc.cn
86-311-69085587
officer
study chair · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: SYH2072

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