Subjects With Cerebral HemorrhagePhase 2NCT05953103
Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage
A Phase 2 study of Subjects With Cerebral Hemorrhage, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subjects With Cerebral Hemorrhage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2023to 2 Apr 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the subject himself or her legal representative has signed the informed consent form;
- aged ≥ 18 years and ≤ 80 years, male or female;
- clinical diagnosis of cerebral hemorrhage, in line with the Chinese Medical Association Neurology Score issued by the "Key Points in the Diagnosis of Various Major Cerebrovascular Diseases in China 2019" cerebral hemorrhage diagnostic criteria [1];
- the bleeding center site is located in the basal ganglia;
- intracranial hematoma volume ≤ 30 ml;
- NIHSS score at enrollment total score ≥ 6 points and ≤ 20 points, and the sum of items 5 and 6 ≥ 2 points;
Show all 9Show fewer
- coma degree is mild to moderate, Glasgow Coma Scale (GCS) ≥ 9 points;
- the time from the onset of this stroke to the start of study treatment is 6 to 24 hours (subjects who sign the informed consent form should receive study treatment as soon as possible, some subjects meet the criteria during the screening period, more than 24 hours when starting study treatment, this patient should terminate the study treatment);
- mRS score of 0 or 1 before onset.
Who cannot join
- allergic to edaravone, dextromethorphan or contained excipients;
- stroke within the past 3 months;
- other concomitant sites of hematoma volume > 5ml, or the need for external ventricular drainage of patients with intraventricular hemorrhage;
- patients with obstructive hydrocephalus;
- drugs, vascular structural damage or coagulation disorders caused by cerebral hemorrhage;
- vital signs unstable, suspected cerebral hernia, deep coma or anisocoria and other critical manifestations;
Show all 17Show fewer
- after this onset has been applied edaravone or dextromethorphan components (such as edaravone injection, Angong Niuhuang pills, Xingnaojing, etc.) of drugs, or has applied a total of more than 2 times the daily recommended dose of the instructions of the following drugs: citicoline, oxiracetam, piracetam, ulinastatin;
- planned surgical evacuation of hematoma, including: craniotomy hematoma evacuation, minimally invasive surgery and decompressive craniectomy;
- ALT or AST > 2.0 × ULN or previously known liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc., previously known kidney disease, renal insufficiency, serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min;
- Suffering from other bleeding disorders, such as thrombocytopenic purpura, bleeding tendency caused by vascular injury, hemophilia and other coagulation disorders, gastrointestinal ulcers, urinary tract bleeding, hemoptysis, etc.;
- Presence of severe, progressive, or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral disease that, in the opinion of the investigator, place the subject at unacceptable risk by participating in this study;
- With severe active bacterial or viral infection;
- Concurrent malignancy or ongoing anti-tumor therapy;
- With severe systemic disease, expected survival < 90 days;
- Patients with severe mental disorders and dementia;
- Patients who are pregnant, lactating and planning pregnancy;
- Reasons for other investigators' unsuitability to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients with intracerebral hemorrhage (ICH). The subject had a clinical diagnosis of ICH, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Sanbexin IV 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Sanbexin IV 62.5 mg; placebo group). Period B is the expansion phase, where the sample size is increased based on the optimal dose selected in Phase A to observe efficacy and safety.
Read the detailed description
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients with intracerebral hemorrhage (ICH). The subject had a clinical diagnosis of ICH, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Sanbexin IV 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Sanbexin IV 62.5 mg; placebo group). Safety was assessed unblinding after the end of study treatment for all subjects in the first dose level group and escalated to the second dose level if the "safe dose" criterion was met, otherwise the trial was terminated; safety was assessed unblinding after the end of study treatment for all subjects in the second dose level group and the 62.5 mg dose level was selected to enter Stage B if the "safe dose" criterion was met, otherwise the 37.5 mg dose level was selected to enter Stage B. Period B is the expansion phase, where the sample size is increased based on the optimal dose selected in Phase A to observe efficacy and safety.
- Conditions
- Subjects With Cerebral Hemorrhage
- Being tested
- Sanbexin IV/Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanbexin IV/PlaceboDrug
Sanbexin/Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sanbexin IV | Experimental | Sanbexin IV 37.5 mg (edaravone 30 mg + dexborneol 7.5 mg), intravenous, twice daily, for 14 consecutive days Receives: Drug: Sanbexin IV/Placebo |
| Placebo | Placebo comparator | Sanbexin mimetic agent, intravenous, twice daily, for 14 consecutive days Receives: Drug: Sanbexin IV/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs) up to 90 days after the first dose of treatment
Measured: up to 90 days after the first dose of treatment
Secondary outcomes (16)
Incidence of deaths up to 90 days after the first dose of treatment
Measured: up to 90 days after the first dose of treatment
Proportion of subjects with AEs, AEs leading to dose interruption or discontinuation, AEs related to study drug, AEs of special interest (AESls), and with abnormal vital signs, abnormal physical examination findings and abnormal laboratory tests results
Measured: up to 90 days after the first dose of treatment
Proportion of subjects with modified Rankin Score (mRS) 0-2, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment
Measured: at 90 days after the first dose of treatment
Proportion of subjects with modified Rankin Score (mRS) 0-1, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment
Measured: at 90 days after the first dose of treatment
Distribution of subjects with modified Rankin Score (mRS), which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 14, 30, 90 days after the first dose of treatment
Measured: at 14, 30, 90 days after the first dose of treatment
Distribution of subjects with Glasgow Outcome Score (GOS), which measures functional outcome, with scores ranging from I (Dead) to V (Good Recovery), at 14, 30, 90 days after the first dose of treatment
Measured: at 14, 30, 90 days after the first dose of treatment
Change from baseline in National Institutes of Health Stroke Scale (NIHSS), which quantifies the impairment caused by a stroke, with scores ranging from 0 (no stroke symptoms) to 42 (the most severe stroke)
Measured: at 14, 30, 90 days after the first dose of treatment
Proportion of subjects with National Institutes of Health Stroke Scale (NIHSS) 0-2, which quantifies the impairment caused by a stroke, with scores ranging from 0 (no stroke symptoms) to 42 (the most severe stroke)
Measured: at 14, 30, 90 days after the first dose of treatment
Proportion of subjects with Barthel index (BI), which measures a person's ability to complete activities of daily, with scores ranging from 0 (fully dependent) to 20 (fully independent), at 90 days after the first dose of treatment
Measured: at 90 days after the first dose of treatment
Imaging endpoints：Change from baseline in perihematomal edema volume (PHEv) and hematoma volume (HV) in milliliters
Measured: at 3, 7, 14 days after the first dose of treatment
Imaging endpoints：Change from baseline in edema extension distance (EED) in millimetres c) Change from baseline in relative perihematomal edema (PHEv/Hv) in odds ratio
Measured: at 3, 7, 14 days after the first dose of treatment
Imaging endpoints: Change from baseline in relative perihematomal edema (PHEv/Hv) in odds ratio
Measured: at 3, 7, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: Cmax: maximum observed plasma concentration for edaravone and dexborneol
Measured: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: Tmax: time to reach the maximum plasma concentration (Cmax) for edaravone and dexborneol
Measured: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: AUC(0-inf): area under the plasma concentration-time curve from time 0 to infinity for edaravone and dexborneol
Measured: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma biomarker endpoints: a) Change from baseline in white blood cell count (WBC) in 109/L; b) Change from baseline in C-reactive protein (CRP), Thioredoxin (TRX) and matrix metalloproteinases (MMP) in mg/L
Measured: at 3, 7, 14 days after the first dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start3 Jul 2023
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Why it stopped: This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Cerebral HemorrhageStudies 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
- Model description
- Initially, 40 participants were enrolled with a 3:1 randomization ratio (30 to the Sanbexin IV group; 10 to the Placebo group). However, the sponsor considered that the placebo group size was insufficient for accurate safety assessment of the investigational drug. Consequently, 20 additional participants were added, revising the randomization ratio to 1:1. Ultimately, the study included 50 participants in the Sanbexin IV group and 30 in the Placebo group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaonan Yao, Study director, Simcere Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953103
- Sponsor's protocol ID
- SIM0355-201
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2023
- Last updated
- 6 Apr 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05953103
- Acronym / sponsor ID
- SIM0355-201
- Conditions
- Subjects With Cerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 19 Jul 2023 (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 SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients with intracerebral hemorrhage (ICH). The subject had a clinical diagnosis of ICH, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Sanbexin IV 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Sanbexin IV 62.5 mg; placebo group). Period B is the expansion phase, where the sample size is increased based on the optimal dose selected in Phase A to observe efficacy and safety.
Detailed description
The SIM0355-201 trial is a multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial with the main study objective of evaluating the safety and tolerability of different doses of Edaravone Dexborneol concentrate injection (Sanbexin IV) combined with conventional medical therapy in patients with intracerebral hemorrhage (ICH). The subject had a clinical diagnosis of ICH, within 6-24 hours from stroke onset to start of study treatment, with the bleeding site in basal ganglia and a hematoma volume ≤ 30 ml at the bleeding site. The trial was divided into two periods (Period A and Period B), with Period A being a dose escalation period divided into two dose levels: the first dose level group (Dose 1 group: Sanbexin IV 37.5 mg; placebo group) and the second dose level group (Dose 2 group: Sanbexin IV 62.5 mg; placebo group). Safety was assessed unblinding after the end of study treatment for all subjects in the first dose level group and escalated to the second dose level if the "safe dose" criterion was met, otherwise the trial was terminated; safety was assessed unblinding after the end of study treatment for all subjects in the second dose level group and the 62.5 mg dose level was selected to enter Stage B if the "safe dose" criterion was met, otherwise the 37.5 mg dose level was selected to enter Stage B. Period B is the expansion phase, where the sample size is increased based on the optimal dose selected in Phase A to observe efficacy and safety.
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
- Initially, 40 participants were enrolled with a 3:1 randomization ratio (30 to the Sanbexin IV group; 10 to the Placebo group). However, the sponsor considered that the placebo group size was insufficient for accurate safety assessment of the investigational drug. Consequently, 20 additional participants were added, revising the randomization ratio to 1:1. Ultimately, the study included 50 participants in the Sanbexin IV group and 30 in the Placebo group
| Arm | Type | Receives |
|---|---|---|
| Sanbexin IV | Experimental | Drug: Sanbexin IV/PlaceboSanbexin IV 37.5 mg (edaravone 30 mg + dexborneol 7.5 mg), intravenous, twice daily, for 14 consecutive days |
| Placebo | Placebo comparator | Drug: Sanbexin IV/PlaceboSanbexin mimetic agent, intravenous, twice daily, for 14 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- the subject himself or her legal representative has signed the informed consent form;
- aged ≥ 18 years and ≤ 80 years, male or female;
- clinical diagnosis of cerebral hemorrhage, in line with the Chinese Medical Association Neurology Score issued by the "Key Points in the Diagnosis of Various Major Cerebrovascular Diseases in China 2019" cerebral hemorrhage diagnostic criteria [1];
- the bleeding center site is located in the basal ganglia;
- intracranial hematoma volume ≤ 30 ml;
Key exclusion criteria (17 listed)
- allergic to edaravone, dextromethorphan or contained excipients;
- stroke within the past 3 months;
- other concomitant sites of hematoma volume > 5ml, or the need for external ventricular drainage of patients with intraventricular hemorrhage;
- patients with obstructive hydrocephalus;
- drugs, vascular structural damage or coagulation disorders caused by cerebral hemorrhage;
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 |
|---|---|---|
| Sanbexin IV/PlaceboSanbexin/Placebo | Drug | Placebo, Sanbexin IV |
Primary outcome
Incidence of serious adverse events (SAEs) up to 90 days after the first dose of treatment
Time frame: up to 90 days after the first dose of treatment
16 secondary outcomes
Incidence of deaths up to 90 days after the first dose of treatment
Time frame: up to 90 days after the first dose of treatment
Proportion of subjects with AEs, AEs leading to dose interruption or discontinuation, AEs related to study drug, AEs of special interest (AESls), and with abnormal vital signs, abnormal physical examination findings and abnormal laboratory tests results
Time frame: up to 90 days after the first dose of treatment
Proportion of subjects with modified Rankin Score (mRS) 0-2, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment
Time frame: at 90 days after the first dose of treatment
Proportion of subjects with modified Rankin Score (mRS) 0-1, which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 90 days after the first dose of treatment
Time frame: at 90 days after the first dose of treatment
Distribution of subjects with modified Rankin Score (mRS), which assesses the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death), at 14, 30, 90 days after the first dose of treatment
Time frame: at 14, 30, 90 days after the first dose of treatment
Distribution of subjects with Glasgow Outcome Score (GOS), which measures functional outcome, with scores ranging from I (Dead) to V (Good Recovery), at 14, 30, 90 days after the first dose of treatment
Time frame: at 14, 30, 90 days after the first dose of treatment
Change from baseline in National Institutes of Health Stroke Scale (NIHSS), which quantifies the impairment caused by a stroke, with scores ranging from 0 (no stroke symptoms) to 42 (the most severe stroke)
Time frame: at 14, 30, 90 days after the first dose of treatment
Proportion of subjects with National Institutes of Health Stroke Scale (NIHSS) 0-2, which quantifies the impairment caused by a stroke, with scores ranging from 0 (no stroke symptoms) to 42 (the most severe stroke)
Time frame: at 14, 30, 90 days after the first dose of treatment
Proportion of subjects with Barthel index (BI), which measures a person's ability to complete activities of daily, with scores ranging from 0 (fully dependent) to 20 (fully independent), at 90 days after the first dose of treatment
Time frame: at 90 days after the first dose of treatment
Imaging endpoints：Change from baseline in perihematomal edema volume (PHEv) and hematoma volume (HV) in milliliters
Time frame: at 3, 7, 14 days after the first dose of treatment
Imaging endpoints：Change from baseline in edema extension distance (EED) in millimetres c) Change from baseline in relative perihematomal edema (PHEv/Hv) in odds ratio
Time frame: at 3, 7, 14 days after the first dose of treatment
Imaging endpoints: Change from baseline in relative perihematomal edema (PHEv/Hv) in odds ratio
Time frame: at 3, 7, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: Cmax: maximum observed plasma concentration for edaravone and dexborneol
Time frame: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: Tmax: time to reach the maximum plasma concentration (Cmax) for edaravone and dexborneol
Time frame: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma pharmacokinetic endpoints: AUC(0-inf): area under the plasma concentration-time curve from time 0 to infinity for edaravone and dexborneol
Time frame: 1 hour pre-dose and 1, 2 hour post-dose at 3, 14 days after the first dose of treatment
Plasma biomarker endpoints: a) Change from baseline in white blood cell count (WBC) in 109/L; b) Change from baseline in C-reactive protein (CRP), Thioredoxin (TRX) and matrix metalloproteinases (MMP) in mg/L
Time frame: at 3, 7, 14 days after the first dose of treatment
Results and safety
The study was stopped early (reason given: This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Subjects With Cerebral Hemorrhage
Active, not recruitingPhase 1/2
Ferritin and Iron Burden in SAH sIRB
SAH, Dementia
Not yet recruitingObservational study
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
Chronic Subdural Hematoma, cSDH
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.
Xiaonan Yao study director
Simcere Pharmaceutical Co., Ltd
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 of Subjects With Cerebral Hemorrhage, run by Simcere Pharmaceutical 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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 Apr 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 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 was stopped early (reason given: This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.). Results are not available in the source record.
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?
Incidence of serious adverse events (SAEs) up to 90 days after the first dose of treatment (time frame: up to 90 days after the first dose of treatment). 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 6 Apr 2026.