HypertensionPhase 4SABERNCT07876544
Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage
A Phase 4 study testing Sitogilun Malate, Allisartan Isoproxil and Amlodipine besylate in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, parallel-controlled Phase IV clinical trial designed to evaluate the efficacy and safety of sitogilun malate tablets in combination with amlodipine besylate tablets in patients with mild to moderate essential hypertension and risk of early kidney damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Sitogilun Malate, Allisartan Isoproxil and Amlodipine besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2026to 31 Dec 2028
- Phase
- Phase 4
- 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
- Aged ≥18 years.
- Male or female.
- Diagnosed with mild to moderate essential hypertension (Grade 1 or Grade 2 hypertension). At both screening and prior to randomization, seated diastolic blood pressure (DBP) must be 90-109 mmHg, with or without seated systolic blood pressure (SBP) of 140-179 mmHg.
- Urinary albumin-to-creatinine ratio (UACR) of 15-30 mg/g, inclusive, at both screening and prior to randomization.
- Fully understands the study and voluntarily agrees to participate and provides written informed consent.
Who cannot join
- Secondary hypertension, as determined by the investigator.
- Severe cardiac disease within 6 months prior to screening, including chronic congestive heart failure (NYHA Class III or IV), acute myocardial infarction, unstable angina, cardiogenic shock, arrhythmias requiring treatment, valvular heart disease, hypertrophic cardiomyopathy, or rheumatic heart disease.
- Severe cerebrovascular disease or events within 6 months prior to screening, including hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, or transient ischemic attack.
- History of Takayasu arteritis, aortic aneurysm, aortic dissection, unilateral or bilateral renal artery stenosis, or severe subclavian artery stenosis.
- Diagnosed or suspected primary glomerulonephritis, renal involvement due to autoimmune disease, diabetic kidney disease, polycystic kidney disease, or other diseases that may cause an elevated UACR at screening.
- Laboratory abnormalities at screening, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN), estimated glomerular filtration rate (eGFR) <30 mL/min, or hemoglobin <90 g/L.
Show all 19Show fewer
- Serum potassium >5.5 mmol/L at screening.
- Poorly controlled diabetes mellitus, defined as fasting blood glucose >11 mmol/L at screening.
- Current or previous diagnosis of hyperthyroidism or hypothyroidism, except for resolved thyroid dysfunction or subclinical hyperthyroidism/hypothyroidism.
- History of gastrointestinal surgery that may significantly alter drug absorption, distribution, metabolism, or excretion.
- Major surgery within 3 months prior to screening or planned major surgery during the study.
- History of malignancy within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal-cell or squamous-cell skin cancer, localized prostate cancer after curative surgery, or papillary thyroid carcinoma.
- Planned use during the study of antihypertensive medications or other medications known to affect blood pressure, such as monoamine oxidase inhibitors, corticosteroids, nonsteroidal anti-inflammatory drugs, oral contraceptives, or antidepressants.
- Abnormal daily sleep-wake schedule (e.g., reversal of the normal day-night schedule) that, in the investigator's judgment, may affect blood pressure.
- Hypersensitivity to any study drug or its excipients, or a history of hypersensitivity to angiotensin II receptor blockers or calcium channel blockers.
- History of drug abuse or alcohol abuse within 1 year prior to screening.
- Participation as a study participant in another drug or medical device clinical trial within 1 month prior to screening.
- Pregnant or breastfeeding women, or participants or their partners planning pregnancy during the study or within 6 months after completion of the study.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, China, 200025
Ji-guang Wang, MD, PhD, 0086-021-64370045 ext. 610911, jiguangw@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sitogilun Malate Tablets Combined With Amlodipine Besylate Tablets in Patients With Mild to Moderate Essential Hypertension and Risk of Early Kidney Damage
This is a multicenter, randomized, double-blind, parallel-controlled Phase IV clinical trial designed to evaluate the efficacy and safety of sitogilun malate tablets in combination with amlodipine besylate tablets in patients with mild to moderate essential hypertension and risk of early kidney damage. Approximately 456 eligible participants will be randomized in a 1:1:1 ratio to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks. The primary efficacy outcome is the change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 8. Secondary efficacy outcomes include changes in mean sitting systolic blood pressure (msSBP), blood pressure response and control rates, ambulatory blood pressure parameters, and urinary albumin-to-creatinine ratio (UACR). Safety will also be evaluated throughout the study.
- Conditions
- Hypertension
- Being tested
- Sitogilun Malate, Allisartan Isoproxil, Amlodipine besylate, Sitogilun Malate Placebo, Allisartan Isoproxil Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitogilun MalateDrug
Sitogilun malate tablets, 100 mg orally once daily for 8 weeks.
Allisartan IsoproxilDrug
Allisartan isoproxil tablets, 240 mg orally once daily for 8 weeks.
Amlodipine besylateDrug
Amlodipine besylate tablets, 5 mg orally once daily for 8 weeks.
Sitogilun Malate PlaceboDrug
Matching placebo for sitogilun malate, two tablets orally once daily for 8 weeks.
Allisartan Isoproxil PlaceboDrug
Matching placebo for allisartan isoproxil, one tablet orally once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sitogilun Malate + Amlodipine | Experimental | Participants will receive sitogilun malate 100 mg (two 50-mg tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. Receives: Drug: Sitogilun Malate; Drug: Amlodipine besylate; Drug: Allisartan Isoproxil Placebo |
| Allisartan Isoproxil + Amlodipine | Active comparator | Participants will receive sitogilun malate placebo (two tablets), allisartan isoproxil 240 mg (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. Receives: Drug: Allisartan Isoproxil; Drug: Amlodipine besylate; Drug: Sitogilun Malate Placebo |
| Placebo + Amlodipine | Placebo comparator | Participants will receive sitogilun malate placebo (two tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. Receives: Drug: Amlodipine besylate; Drug: Sitogilun Malate Placebo; Drug: Allisartan Isoproxil Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Mean sitting diastolic blood pressure (msDBP) will be measured in mmHg. The change from baseline to Week 8 will be calculated. A greater reduction in msDBP indicates a greater blood pressure-lowering effect.
Measured: Baseline to Week 8
Secondary outcomes (7)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 4
Measured: Baseline to Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 4
Measured: Baseline to Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Measured: Baseline to Week 8
Overall Blood Pressure Response Rate at Weeks 4 and 8
Measured: Weeks 4 and 8
Blood Pressure Control Rate at Weeks 4 and 8
Measured: Weeks 4 and 8
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters at Week 8
Measured: Baseline to Week 8
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 8
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start22 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized in a 1:1:1 ratio to three parallel treatment groups to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876544
- Sponsor's protocol ID
- SABER
- Acronym
- SABER
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during this trial are not planned to be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sitogilun Malate Tablets Combined With Amlodipine Besylate Tablets in Patients With Mild to Moderate Essential Hypertension and Risk of Early Kidney Damage
- ClinicalTrials.gov ID
- NCT07876544
- Acronym / sponsor ID
- SABER / SABER
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 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.
This is a multicenter, randomized, double-blind, parallel-controlled Phase IV clinical trial designed to evaluate the efficacy and safety of sitogilun malate tablets in combination with amlodipine besylate tablets in patients with mild to moderate essential hypertension and risk of early kidney damage. Approximately 456 eligible participants will be randomized in a 1:1:1 ratio to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks. The primary efficacy outcome is the change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 8. Secondary efficacy outcomes include changes in mean sitting systolic blood pressure (msSBP), blood pressure response and control rates, ambulatory blood pressure parameters, and urinary albumin-to-creatinine ratio (UACR). Safety will also be evaluated throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Eligible participants will be randomized in a 1:1:1 ratio to three parallel treatment groups to receive sitogilun malate plus amlodipine, allisartan isoproxil plus amlodipine, or placebo plus amlodipine for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Sitogilun Malate + Amlodipine | Experimental | Drug: Sitogilun Malate, Drug: Amlodipine besylate, Drug: Allisartan Isoproxil PlaceboParticipants will receive sitogilun malate 100 mg (two 50-mg tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. |
| Allisartan Isoproxil + Amlodipine | Active comparator | Drug: Allisartan Isoproxil, Drug: Amlodipine besylate, Drug: Sitogilun Malate PlaceboParticipants will receive sitogilun malate placebo (two tablets), allisartan isoproxil 240 mg (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. |
| Placebo + Amlodipine | Placebo comparator | Drug: Amlodipine besylate, Drug: Sitogilun Malate Placebo, Drug: Allisartan Isoproxil PlaceboParticipants will receive sitogilun malate placebo (two tablets), allisartan isoproxil placebo (one tablet), and amlodipine besylate 5 mg (one tablet) orally once daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years.
- Male or female.
- Diagnosed with mild to moderate essential hypertension (Grade 1 or Grade 2 hypertension). At both screening and prior to randomization, seated diastolic blood pressure (DBP) must be 90-109 mmHg, with or without seated systolic blood pressure (SBP) of 140-179 mmHg.
- Urinary albumin-to-creatinine ratio (UACR) of 15-30 mg/g, inclusive, at both screening and prior to randomization.
- Fully understands the study and voluntarily agrees to participate and provides written informed consent.
Key exclusion criteria (19 listed)
- Secondary hypertension, as determined by the investigator.
- Severe cardiac disease within 6 months prior to screening, including chronic congestive heart failure (NYHA Class III or IV), acute myocardial infarction, unstable angina, cardiogenic shock, arrhythmias requiring treatment, valvular heart disease, hypertrophic cardiomyopathy, or rheumatic heart disease.
- Severe cerebrovascular disease or events within 6 months prior to screening, including hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, or transient ischemic attack.
- History of Takayasu arteritis, aortic aneurysm, aortic dissection, unilateral or bilateral renal artery stenosis, or severe subclavian artery stenosis.
- Diagnosed or suspected primary glomerulonephritis, renal involvement due to autoimmune disease, diabetic kidney disease, polycystic kidney disease, or other diseases that may cause an elevated UACR at screening.
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 |
|---|---|---|
| Sitogilun MalateSitogilun malate tablets, 100 mg orally once daily for 8 weeks. | Drug | Sitogilun Malate + Amlodipine |
| Allisartan IsoproxilAllisartan isoproxil tablets, 240 mg orally once daily for 8 weeks. | Drug | Allisartan Isoproxil + Amlodipine |
| Amlodipine besylateAmlodipine besylate tablets, 5 mg orally once daily for 8 weeks. | Drug | Allisartan Isoproxil + Amlodipine, Placebo + Amlodipine, Sitogilun Malate + Amlodipine |
| Sitogilun Malate PlaceboMatching placebo for sitogilun malate, two tablets orally once daily for 8 weeks. | Drug | Allisartan Isoproxil + Amlodipine, Placebo + Amlodipine |
| Allisartan Isoproxil PlaceboMatching placebo for allisartan isoproxil, one tablet orally once daily for 8 weeks. | Drug | Placebo + Amlodipine, Sitogilun Malate + Amlodipine |
Primary outcome
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Time frame: Baseline to Week 8
Mean sitting diastolic blood pressure (msDBP) will be measured in mmHg. The change from baseline to Week 8 will be calculated. A greater reduction in msDBP indicates a greater blood pressure-lowering effect.
7 secondary outcomes
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 4
Time frame: Baseline to Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 4
Time frame: Baseline to Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Time frame: Baseline to Week 8
Overall Blood Pressure Response Rate at Weeks 4 and 8
Time frame: Weeks 4 and 8
Blood Pressure Control Rate at Weeks 4 and 8
Time frame: Weeks 4 and 8
Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters at Week 8
Time frame: Baseline to Week 8
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) at Week 8
Time frame: Baseline to Week 8
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 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this trial are not planned to be made publicly available.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitogilun Malate, Allisartan Isoproxil and Amlodipine besylate in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ji-guang Wang, MD, PhD (021 64370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 (time frame: Baseline to 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 15 Oct 2026.