Essential HypertensionPhase 2NCT07700875
A Phase II Clinical Study of QR12000 Compound Tablets in Patients With Moderate to Severe Essential Hypertension
A Phase 2 study testing QR12000 Compound Tablets 75 mg, QR12000 Compound Tablets 150 mg and QR01019 potassium salt 50 mg in people with Essential Hypertension, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to compare the antihypertensive effect of QR12000 Compound Tablets with its single component, QR01019 potassium salt, and with valsartan in patients with moderate to severe essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- QR12000 Compound Tablets 75 mg, QR12000 Compound Tablets 150 mg and QR01019 potassium salt 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to 11 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to understand and willing to strictly follow the clinical trial protocol to complete the study, and have signed the informed consent form.
- Male or female aged 18 to 75 years (inclusive), with a body mass index (BMI) ≤ 30 kg/m².
- Patients with moderate to severe essential hypertension:
- Newly diagnosed essential hypertension or a history of hypertension but no antihypertensive medication within 4 weeks prior to screening. Qualified subjects will enter the placebo run-in period. The subject's blood pressure at the Screening Visit (V1) and Baseline (V3) must meet the following criteria: at V1, mean sitting systolic blood pressure (msSBP) > 140 mmHg and/or mean sitting diastolic blood pressure (msDBP) > 90 mmHg; at V3, 160 mmHg ≤ msSBP < 190 mmHg and/or 100 mmHg ≤ msDBP < 120 mmHg.
- Subjects who have been taking antihypertensive medications other than the study drugs as regularly as possible (missed doses ≤ 2 per week) for at least 4 weeks prior to screening, but whose blood pressure remains uncontrolled. After qualifying, subjects will discontinue their previous medications on the day they enter the placebo run-in period. Blood pressure criteria at V1 and V3 must meet: V1 msSBP > 140 mmHg and/or msDBP > 90 mmHg; V3 160 mmHg ≤ msSBP < 190 mmHg and/or 100 mmHg ≤ msDBP < 120 mmHg. [Note: "Study drugs" here refer to all investigational treatments in this study (excluding placebo) and other marketed drugs with identical active ingredients, mainly including valsartan 160 mg, sacubitril/valsartan sodium 200 mg, and azilsartan medoxomil potassium 40 mg.]
- Subjects who are able to communicate and comply with all study requirements, and demonstrate good medication adherence.
- The subject and their sexual partner are willing to have no plans for pregnancy and voluntarily use effective contraception from 2 weeks before screening until 6 months after the last dose of study drug, have no plans for sperm or egg donation, and agree to use one or more non-pharmacological contraceptive measures during sexual intercourse from 2 weeks before screening until 1 month after the last dose of study drug
Who cannot join
- Known or suspected secondary hypertension (including but not limited to: primary aldosteronism, pheochromocytoma, Cushing's syndrome, renal hypertension, drug-induced hypertension, etc.).
- Known history of orthostatic hypotension or frequent hypotension after taking antihypertensive medications.
- Planned or concomitant use of other antihypertensive drugs (other than study drugs) during the trial, such as calcium channel blockers (CCB), angiotensin-converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), diuretics, β-blockers, α-blockers, vasodilators, or traditional Chinese medicines with antihypertensive effects.
- Planned or concomitant use of non-antihypertensive drugs that may affect blood pressure during the trial. Note: Topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoids (with very low systemic absorption) are allowed. Short-term (≤3 days) systemic glucocorticoid use (intravenous or oral) for prophylaxis (e.g., contrast agent allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity to contact allergens) is permitted; however, systemic glucocorticoids must not be used within 7 days before the primary endpoint.
- Planned or concomitant use of drugs that may affect the metabolism of the investigational drug or comparator, as well as other chemical drugs, biological products, traditional Chinese medicines, or natural medicines deemed unsuitable by the investigator.
- History of severe cerebrovascular disease within 6 months prior to enrollment, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack, cerebral infarction, etc.
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- History of any of the following severe cardiovascular diseases within 6 months prior to enrollment: chronic heart failure (New York Heart Association [NYHA] Class III or IV), acute coronary syndrome, cardiogenic shock, any type of cardiomyopathy, rheumatic heart disease, arrhythmias requiring treatment, and valvular heart disease requiring treatment.
- Severe or malignant retinopathy. Severe retinopathy is defined as retinal hemorrhage, microaneurysms, cotton-wool spots, hard exudates, or a combination thereof; malignant retinopathy is defined as severe retinopathy plus optic disc edema.
- History of angioedema, hereditary or idiopathic angioedema.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) > 2 × upper limit of normal (ULN) (based on the local laboratory reference ranges); serum creatinine (Cr) > 1.5 × ULN (based on the local laboratory reference ranges).
- Diabetes mellitus with poor glycemic control (fasting blood glucose > 11.1 mmol/L).
- Severe depression, anxiety disorder, or severe sleep disorder requiring combined treatment with three or more medications within 12 months before screening.
- Subjects with aortic aneurysm or dissecting aneurysm, history of percutaneous transluminal coronary angioplasty, or cardiac surgery.
- History or current diagnosis of severe bronchial asthma or severe obstructive pulmonary disease.
- Advanced peripheral arterial occlusive disease or Raynaud's syndrome.
- History of malignancy (except for non-metastatic basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, that were diagnosed and have been stable after appropriate treatment or resection within the past 5 years).
- History of gastrointestinal surgery that may significantly alter drug absorption, distribution, metabolism, or excretion, or presence of severe gastrointestinal disease, dysphagia, or recurrent vomiting leading to difficulty with food intake or medication administration.
- Subjects with severe autoimmune disease (e.g., chronic rheumatoid arthritis, systemic lupus erythematosus), severe hematopoietic system disease, or severe chronic inflammatory disease requiring long-term anti-inflammatory treatment (except for those taking only low-dose aspirin ≤ 100 mg per day).
- Participation in any interventional clinical trial within 3 months prior to screening, or plans to participate in another clinical study during this trial or within 3 months after its completion.
- Evidence of alcohol abuse (average consumption of ≥ 14 units of alcohol per week, where 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine) or drug abuse within 6 months prior to screening, which in the investigator's opinion would interfere with the subject's understanding or completion of the study.
- Positive pregnancy test, lactating women, or women planning to become pregnant.
- Abnormal infectious disease screening results at screening that are judged by the investigator to be clinically significant and require treatment.
- Known allergy to the study drugs, similar drugs (e.g., other combination products containing valsartan, azilsartan, or sacubitril), or related excipients.
- Patients with severe neurological or psychiatric disorders that prevent adequate understanding and cooperation.
- Subjects who, in the investigator's judgment, cannot tolerate the 1-week discontinuation of prior antihypertensive medications during the placebo run-in period and baseline, or those whose prior antihypertensive medications (e.g., perindopril) require a complete washout period of ≥ 2 weeks (≥ 5 half-lives) as assessed by the investigator.
- Poor medication compliance during the placebo run-in period (defined as actual total amount of placebo taken < 80% of the planned total dose) or other compliance issues judged by the investigator.
- Subjects engaged in working at heights, motor vehicle driving, or operating hazardous machinery.
- Any concurrent condition that, in the investigator's opinion, may interfere with study assessments, or participation in this study that may pose an increased risk to the subject.
- Subjects judged by the investigator to be unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Efficacy and Safety of QR12000 Compound Tablets in Patients With Moderate to Severe Essential Hypertension
The purpose of this study is to compare the antihypertensive effect of QR12000 Compound Tablets with its single component, QR01019 potassium salt, and with valsartan in patients with moderate to severe essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- QR12000 Compound Tablets 75 mg, QR12000 Compound Tablets 75 mg placebo, QR12000 Compound Tablets 150 mg, QR12000 Compound Tablets 150 mg placebo, QR01019 potassium salt 50 mg
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR12000 Compound Tablets 75 mgDrug
QR12000 Compound Tablets 75 mg QD
QR12000 Compound Tablets 75 mg placeboDrug
Matching placebo of QR12000 Compound Tablets 75 mg QD
QR12000 Compound Tablets 150 mgDrug
QR12000 Compound Tablets 150 mg QD
QR12000 Compound Tablets 150 mg placeboDrug
Matching placebo of QR12000 Compound Tablets 150 mg QD
QR01019 potassium salt 50 mgDrug
QR01019 potassium salt 50 mg QD
QR01019 potassium salt 50 mg placeboDrug
Matching placebo of QR01019 potassium salt 50 mg QD
Sacubitril / valsartan 200 mgDrug
Sacubitril / valsartan 200 mg QD
Sacubitril / valsartan 200 mg placeboDrug
Matching placebo of Sacubitril / valsartan 200 mg QD
Valsartan 160 mgDrug
Valsartan 160 mg QD
Valsartan 160 mg placeboDrug
Matching placebo of Valsartan 160mg QD
| Study group | Role | What they receive |
|---|---|---|
| QR12000 Compound Tablets 75mg | Experimental | Participants will be treated with one tablet of QR12000 Compound Tablets 75mg Receives: Drug: QR12000 Compound Tablets 75 mg; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo |
| QR12000 Compound Tablets 150mg | Experimental | Participants will be treated with one tablet of QR12000 Compound Tablets 150mg Receives: Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo |
| QR01019 potassium salt 50 mg | Experimental | Participants will be treated with one tablet of QR01019 potassium salt 50 mg Receives: Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo |
| Sacubitril/valsartan 200 mg | Active comparator | Participants will be treated with one tablet of Sacubitril/valsartan 200 mg Receives: Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg; Drug: Valsartan 160 mg placebo |
| Valsartan 160mg | Active comparator | Participants will be treated with one tablet of Valsartan160 mg Receives: Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
The change in msSBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8.
Secondary outcomes (4)
Percentage of Participants Achieving BP Response
BP Response is defined as msSBP <140 mm Hg and/or a reduction of ≥20 mm Hg from Baseline and msDBP <90 mm Hg and/or a reduction of ≥10 mm Hg from Baseline at week 2, week 4, week 6 , and week 8.
Measured: Baseline, week 2, week 4, week 6 , and week 8.
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
The change in msDBP measured at Week 2, Week 4, Week 6, and Week 8 relative to baseline.
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
The change in msSBP measured at Week 2, Week 4, Week 6, and Week 8 relative to baseline.
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8.
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) at Week 8
The change in maSBP/maDBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start29 Dec 2022
- Primary completion20 Aug 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700875
- Sponsor's protocol ID
- QR12000-GXY-2-01
- Other IDs
- CTR20222568
- Status last verified
- Oct 2022
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Efficacy and Safety of QR12000 Compound Tablets in Patients With Moderate to Severe Essential Hypertension
- ClinicalTrials.gov ID
- NCT07700875
- Acronym / sponsor ID
- QR12000-GXY-2-01
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to compare the antihypertensive effect of QR12000 Compound Tablets with its single component, QR01019 potassium salt, and with valsartan in patients with moderate to severe essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| QR12000 Compound Tablets 75mg | Experimental | Drug: QR12000 Compound Tablets 75 mg, Drug: QR12000 Compound Tablets 150 mg placebo, Drug: QR01019 potassium salt 50 mg placebo, Drug: Sacubitril / valsartan 200 mg placebo, Drug: Valsartan 160 mg placeboParticipants will be treated with one tablet of QR12000 Compound Tablets 75mg |
| QR12000 Compound Tablets 150mg | Experimental | Drug: QR12000 Compound Tablets 75 mg placebo, Drug: QR12000 Compound Tablets 150 mg, Drug: QR01019 potassium salt 50 mg placebo, Drug: Sacubitril / valsartan 200 mg placebo, Drug: Valsartan 160 mg placeboParticipants will be treated with one tablet of QR12000 Compound Tablets 150mg |
| QR01019 potassium salt 50 mg | Experimental | Drug: QR12000 Compound Tablets 75 mg placebo, Drug: QR12000 Compound Tablets 150 mg placebo, Drug: QR01019 potassium salt 50 mg, Drug: Sacubitril / valsartan 200 mg placebo, Drug: Valsartan 160 mg placeboParticipants will be treated with one tablet of QR01019 potassium salt 50 mg |
| Sacubitril/valsartan 200 mg | Active comparator | Drug: QR12000 Compound Tablets 75 mg placebo, Drug: QR12000 Compound Tablets 150 mg placebo, Drug: QR01019 potassium salt 50 mg placebo, Drug: Sacubitril / valsartan 200 mg, Drug: Valsartan 160 mg placeboParticipants will be treated with one tablet of Sacubitril/valsartan 200 mg |
| Valsartan 160mg | Active comparator | Drug: QR12000 Compound Tablets 75 mg placebo, Drug: QR12000 Compound Tablets 150 mg placebo, Drug: QR01019 potassium salt 50 mg placebo, Drug: Sacubitril / valsartan 200 mg placebo, Drug: Valsartan 160 mgParticipants will be treated with one tablet of Valsartan160 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are able to understand and willing to strictly follow the clinical trial protocol to complete the study, and have signed the informed consent form.
- Male or female aged 18 to 75 years (inclusive), with a body mass index (BMI) ≤ 30 kg/m².
- Patients with moderate to severe essential hypertension:
- Subjects who are able to communicate and comply with all study requirements, and demonstrate good medication adherence.
- The subject and their sexual partner are willing to have no plans for pregnancy and voluntarily use effective contraception from 2 weeks before screening until 6 months after the last dose of study drug, have no plans for sperm or egg donation, and agree to use one or more non-pharmacological contraceptive measures during sexual intercourse from 2 weeks before screening until 1 month after the last dose of study drug
Key exclusion criteria (29 listed)
- Known or suspected secondary hypertension (including but not limited to: primary aldosteronism, pheochromocytoma, Cushing's syndrome, renal hypertension, drug-induced hypertension, etc.).
- Known history of orthostatic hypotension or frequent hypotension after taking antihypertensive medications.
- Planned or concomitant use of other antihypertensive drugs (other than study drugs) during the trial, such as calcium channel blockers (CCB), angiotensin-converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), diuretics, β-blockers, α-blockers, vasodilators, or traditional Chinese medicines with antihypertensive effects.
- Planned or concomitant use of non-antihypertensive drugs that may affect blood pressure during the trial. Note: Topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoids (with very low systemic absorption) are allowed. Short-term (≤3 days) systemic glucocorticoid use (intravenous or oral) for prophylaxis (e.g., contrast agent allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity to contact allergens) is permitted; however, systemic glucocorticoids must not be used within 7 days before the primary endpoint.
- Planned or concomitant use of drugs that may affect the metabolism of the investigational drug or comparator, as well as other chemical drugs, biological products, traditional Chinese medicines, or natural medicines deemed unsuitable by the investigator.
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 |
|---|---|---|
| QR12000 Compound Tablets 75 mgQR12000 Compound Tablets 75 mg QD | Drug | QR12000 Compound Tablets 75mg |
| QR12000 Compound Tablets 75 mg placeboMatching placebo of QR12000 Compound Tablets 75 mg QD | Drug | QR01019 potassium salt 50 mg, QR12000 Compound Tablets 150mg, Sacubitril/valsartan 200 mg, Valsartan 160mg |
| QR12000 Compound Tablets 150 mgQR12000 Compound Tablets 150 mg QD | Drug | QR12000 Compound Tablets 150mg |
| QR12000 Compound Tablets 150 mg placeboMatching placebo of QR12000 Compound Tablets 150 mg QD | Drug | QR01019 potassium salt 50 mg, QR12000 Compound Tablets 75mg, Sacubitril/valsartan 200 mg, Valsartan 160mg |
| QR01019 potassium salt 50 mgQR01019 potassium salt 50 mg QD | Drug | QR01019 potassium salt 50 mg |
| QR01019 potassium salt 50 mg placeboMatching placebo of QR01019 potassium salt 50 mg QD | Drug | QR12000 Compound Tablets 150mg, QR12000 Compound Tablets 75mg, Sacubitril/valsartan 200 mg, Valsartan 160mg |
| Sacubitril / valsartan 200 mgSacubitril / valsartan 200 mg QD | Drug | Sacubitril/valsartan 200 mg |
| Sacubitril / valsartan 200 mg placeboMatching placebo of Sacubitril / valsartan 200 mg QD | Drug | QR01019 potassium salt 50 mg, QR12000 Compound Tablets 150mg, QR12000 Compound Tablets 75mg, Valsartan 160mg |
| Valsartan 160 mgValsartan 160 mg QD | Drug | Valsartan 160mg |
| Valsartan 160 mg placeboMatching placebo of Valsartan 160mg QD | Drug | QR01019 potassium salt 50 mg, QR12000 Compound Tablets 150mg, QR12000 Compound Tablets 75mg, Sacubitril/valsartan 200 mg |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Time frame: Baseline and week 8.
The change in msSBP measured at Week 8 relative to baseline.
4 secondary outcomes
Percentage of Participants Achieving BP Response
Time frame: Baseline, week 2, week 4, week 6 , and week 8.
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8.
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) at Week 8
Time frame: Baseline and week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QR12000 Compound Tablets 75 mg, QR12000 Compound Tablets 150 mg and QR01019 potassium salt 50 mg in people with Essential Hypertension, run by Wuhan Createrna Science and Technology Co., Ltd 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 7 inclusion and 29 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: finished, as of the sponsor's last update on 14 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 (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 14 Jul 2026.