HypertensionPhase 4NCT03946514
Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients
A Phase 4 study testing losartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS) 2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- losartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Aug 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or Women aged between 18 years will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself.
Who cannot join
- suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
About this study
Official title: Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)
- Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
- Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
- Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence.
- Objective: To evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy.
- Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan/hydrochlorothiazide single-pill fixed combination and amlodipine/hydrochlorothiazide.
- Study population: Men and Women aged over 18 years (n=180) meeting the inclusion/exclusion criteria.
- Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: 8 weeks.
- Sample size: a total of 180 patients should be enrolled in the combination.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to August 2024. All patients should be followed up before August 2024.
Read the detailed description
- Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
- Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
- Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence, especially randomized controlled clinical trials with ambulatory or home blood pressure monitoring as the main evaluation method.
- Objective The primary objective is to evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy. The secondary objective are to compare the 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure between the losartan 100 mg/hydrochlorothiazide 25 mg group and the amlodipine besylate 5 mg/hydrochlorothiazide 25 mg group after 8 weeks of antihypertensive treatment; to compare the changes in blood glucose, blood lipids, blood electrolytes, serum creatinine, blood uric acid and other biochemical parameters.
- Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination group and amlodipine besylate 5 mg+hydrochlorothiazide 25 mg group.
- Study population: Men or Women aged over 18 years (n=180) will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself. Exclusion criteria included: suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.
- Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: Sitting office blood pressures should measured by an OMRON device. Medical history should be recorded. Clinical examinations including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. During the 4-week follow-up visit, office blood pressures, serum electrolyte should be measure, adverse events and medication assignment should be recorded. A one-week home blood pressure measurements should be performed immediately before the follow-up visit. During the 8-week follow-up visit, clinical examinations similar with baseline including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed.
- Sample size and statistical analysis: At least 90 eligible patients should be enrolled in each group, and a total of 180 patients should be enrolled in total. Data will be analyzed by using the SAS software. T-tests will be used to compare the parameters between groups and the difference between the two groups with the calculation of 95% confidence interval. In addition, a covariance analysis will also be used in the analysis of baseline parameters.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to August 2024. All patients should be followed up before August 2024. Database construction and statistical analysis will be conducted at the same time, appropriate domestic and international conferences will be selected to publish the research results. The main results will be published in international professional medical journals.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
- Conditions
- Hypertension
- Being tested
- losartan/hydrochlorothiazide, amlodipine/hydrochlorothiazide
- Keywords
- Blood pressure, single-pill fixed combination, losartan/hydrochlorothiazide, amlodipine/hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartan/hydrochlorothiazideDrug
losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination
amlodipine/hydrochlorothiazideDrug
amlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet)
| Study group | Role | What they receive |
|---|---|---|
| losartan/hydrochlorothiazide group | Experimental | Not described Receives: Drug: losartan/hydrochlorothiazide |
| amlodipine/hydrochlorothiazide group | Active comparator | Not described Receives: Drug: amlodipine/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up
Measured: 8 weeks
Blood pressure control rate
The blood pressure controlled rate after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (1)
Ambulatory blood pressure change
The changes of ambulatory blood pressure between two treatment groups after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
1 Sep 201831 Aug 2024
- First posted10 May 2019
- Study start1 Sep 2018
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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 patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
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
- NCT03946514
- Sponsor's protocol ID
- FOCUS
- Status last verified
- Mar 2025
- First submitted
- 5 May 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients (FOCUS)
- ClinicalTrials.gov ID
- NCT03946514
- Acronym / sponsor ID
- FOCUS
- Conditions
- Hypertension
- Keywords
- Blood pressure, single-pill fixed combination, losartan/hydrochlorothiazide, amlodipine/hydrochlorothiazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 10 May 2019 (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.
- Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
- Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
- Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence.
- Objective: To evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy.
- Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan/hydrochlorothiazide single-pill fixed combination and amlodipine/hydrochlorothiazide.
- Study population: Men and Women aged over 18 years (n=180) meeting the inclusion/exclusion criteria.
- Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: 8 weeks.
- Sample size: a total of 180 patients should be enrolled in the combination.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to August 2024. All patients should be followed up before August 2024.
Detailed description
- Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
- Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
- Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence, especially randomized controlled clinical trials with ambulatory or home blood pressure monitoring as the main evaluation method.
- Objective The primary objective is to evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy. The secondary objective are to compare the 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure between the losartan 100 mg/hydrochlorothiazide 25 mg group and the amlodipine besylate 5 mg/hydrochlorothiazide 25 mg group after 8 weeks of antihypertensive treatment; to compare the changes in blood glucose, blood lipids, blood electrolytes, serum creatinine, blood uric acid and other biochemical parameters.
- Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination group and amlodipine besylate 5 mg+hydrochlorothiazide 25 mg group.
- Study population: Men or Women aged over 18 years (n=180) will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself. Exclusion criteria included: suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.
- Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: Sitting office blood pressures should measured by an OMRON device. Medical history should be recorded. Clinical examinations including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. During the 4-week follow-up visit, office blood pressures, serum electrolyte should be measure, adverse events and medication assignment should be recorded. A one-week home blood pressure measurements should be performed immediately before the follow-up visit. During the 8-week follow-up visit, clinical examinations similar with baseline including ambulatory blood pressure, home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed.
- Sample size and statistical analysis: At least 90 eligible patients should be enrolled in each group, and a total of 180 patients should be enrolled in total. Data will be analyzed by using the SAS software. T-tests will be used to compare the parameters between groups and the difference between the two groups with the calculation of 95% confidence interval. In addition, a covariance analysis will also be used in the analysis of baseline parameters.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to August 2024. All patients should be followed up before August 2024. Database construction and statistical analysis will be conducted at the same time, appropriate domestic and international conferences will be selected to publish the research results. The main results will be published in international professional medical journals.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
| Arm | Type | Receives |
|---|---|---|
| losartan/hydrochlorothiazide group | Experimental | Drug: losartan/hydrochlorothiazide |
| amlodipine/hydrochlorothiazide group | Active comparator | Drug: amlodipine/hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or Women aged between 18 years will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself.
Key exclusion criteria (1 listed)
- suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium >5.5 mmol/L or <3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.
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 |
|---|---|---|
| losartan/hydrochlorothiazidelosartan 100 mg/hydrochlorothiazide 25 mg single-pill combination | Drug | losartan/hydrochlorothiazide group |
| amlodipine/hydrochlorothiazideamlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet) | Drug | amlodipine/hydrochlorothiazide group |
Primary outcome
Adverse events
Time frame: 8 weeks
Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up
Blood pressure control rate
Time frame: 8 weeks
The blood pressure controlled rate after 8 weeks of treatment
1 secondary outcome
Ambulatory blood pressure change
Time frame: 8 weeks
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 30 Mar 2025.
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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 4 study testing losartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide 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 1 inclusion and 1 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 30 Mar 2025. 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 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?
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?
Adverse events (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 30 Mar 2025.