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

November 2, 2026 updated by: InnovStone Therapeutics Limited

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of SYH2072 Tablets for Uncontrolled Hypertension (Including Resistant Hypertension) in Patients on Two or More Antihypertensive Agents

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Information Group NA officer
  • Phone Number: 86-311-69085587
  • Email: ctr-contact@cspc.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntarily participate in this study and sign the informed consent 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:

  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 malignancy 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 investigational drug, and/or who do not agree to use effective non-pharmacological contraception;
  8. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose group

SYH2072 Tablets
Drug: SYH2072 Tablets

Low-dose

Drug: SYH2072 Tablets

Middle-dose

Drug: SYH2072 Tablets

high-dose
Experimental: Middle-dose group

SYH2072 Tablets
Drug: placebo

placebo

Drug: SYH2072 Tablets

Low-dose

Drug: SYH2072 Tablets

Middle-dose

Drug: SYH2072 Tablets

high-dose
Experimental: High-dose group

SYH2072 Tablets
Drug: SYH2072 Tablets

Low-dose

Drug: SYH2072 Tablets

Middle-dose

Drug: SYH2072 Tablets

high-dose
Placebo Comparator: Placebo group

Placebo
Drug: placebo

placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean seated systolic blood pressure (msSBP)
Time Frame: at week 12

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnovStone Therapeutics Limited

Investigators

  • Study Chair: officer, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 13, 2026

Primary Completion (Estimated)

July 22, 2027

Study Completion (Estimated)

November 28, 2027

Study Registration Dates

First Submitted

October 28, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SYH2072-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe