Atrial FibrillationPhase 4NCT04111419
Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation
A Phase 4 study testing Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET and Allisartan Isoproxil in people with Atrial Fibrillation and Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION) 2. Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet). 3. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET and Allisartan Isoproxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men or women aged over 65 years. patients who never took 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.
- Patient who sign the written consent and are able to go to the clinic by him/herself.
Who cannot join
- suspected or confirmed secondary hypertension; taking two or more antihypertensive drugs; patients who never take antihypertensive drugs with a clinic blood pressure over 180/110 mmHg or treated patients with a clinic blood pressure over 160/100 mmHg or patients with a home blood pressure below 130/80 mmHg; 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 >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²; severe OSAS; 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: Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION)
- Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)
- Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).
- Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol.
- Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol.
- Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet).
- Study population: Men and Women aged over 65 years (n=1200) meeting the inclusion/exclusion criteria.
- Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day.
- Follow up: 3 years.
- Sample size: a total of 1200 patients should be enrolled in the combination.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2019, recruitment will start. Patients enrollment will be performed between November 2019 to November 2020. All patients should be followed up before December 2023.
Read the detailed description
- Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)
- Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).
- Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol.
- Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol, especially in hypertensive patients with atrial fibrillation.
- Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet).
- Study population: Men or women aged over 65 years (n=1200) will be screened for atrial fibrillation. Atrial fibrillation patients who never took 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 recruited. 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 >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²; elderly care patients; or patients who are participating in other clinical trials.
- Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine (5 mg/tablet)+ once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: Sitting office blood pressures and electrocardiogram should measured by an OMRON device. Medical history should be recorded. Clinical examinations including home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. Patients should be followed up every three months. Before the follow-up, patients should perform a one-week home blood pressure monitoring.
- Sample size and statistical analysis: At least 300 eligible patients should be enrolled in each group, and a total of 1200 patients should be enrolled in total. Data will be analyzed by using the SAS software. ANOVA will be used to compare the parameters between groups and the difference between the four 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 2019, recruitment will start. Patients enrollment will be performed between October 2019 to October 2020. All patients should be followed up before December 2023. 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
- Atrial Fibrillation, Hypertension
- Being tested
- Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET, Allisartan Isoproxil
- Keywords
- intensive management, blood pressure, blood cholesterol
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLETDrug
amlodipine/atorvastatin (5/20mg tablet) once a day
Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLETDrug
amlodipine/atorvastatin (5/10mg tablet) once a day
Allisartan IsoproxilDrug
allisartan (240mg/tablet) once a day
| Study group | Role | What they receive |
|---|---|---|
| Intensive blood pressure and cholesterol control | Experimental | Not described Receives: Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET; Drug: Allisartan Isoproxil |
| Intensive blood pressure and routine cholesterol control | Active comparator | Not described Receives: Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET; Drug: Allisartan Isoproxil |
| Routine blood pressure and intensive cholesterol control | Active comparator | Not described Receives: Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET |
| Routine blood pressure and cholesterol control | Active comparator | Not described Receives: Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined cardiovascular end-point events
Fatal and non-fatal stroke, acute MI and cardiovascular death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
1 Jul 202031 Dec 2026
- First posted1 Oct 2019
- Study start1 Jul 2020
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day.
- Masking
- None (open label)
- Enrolment
- 1,200 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, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111419
- Sponsor's protocol ID
- IMPRESSION
- Status last verified
- Aug 2025
- First submitted
- 29 Sep 2019
- Last updated
- 13 Aug 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION)
- ClinicalTrials.gov ID
- NCT04111419
- Acronym / sponsor ID
- IMPRESSION
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- intensive management, blood pressure, blood cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 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: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)
- Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).
- Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol.
- Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol.
- Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet).
- Study population: Men and Women aged over 65 years (n=1200) meeting the inclusion/exclusion criteria.
- Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day.
- Follow up: 3 years.
- Sample size: a total of 1200 patients should be enrolled in the combination.
- Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2019, recruitment will start. Patients enrollment will be performed between November 2019 to November 2020. All patients should be followed up before December 2023.
Detailed description
- Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION)
- Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet).
- Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol.
- Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol, especially in hypertensive patients with atrial fibrillation.
- Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet).
- Study population: Men or women aged over 65 years (n=1200) will be screened for atrial fibrillation. Atrial fibrillation patients who never took 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 recruited. 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 >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²; elderly care patients; or patients who are participating in other clinical trials.
- Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine (5 mg/tablet)+ once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
- Follow up: Sitting office blood pressures and electrocardiogram should measured by an OMRON device. Medical history should be recorded. Clinical examinations including home blood pressure, electrocardiogram, blood and urine routine tests and biochemical tests should be performed. Patients should be followed up every three months. Before the follow-up, patients should perform a one-week home blood pressure monitoring.
- Sample size and statistical analysis: At least 300 eligible patients should be enrolled in each group, and a total of 1200 patients should be enrolled in total. Data will be analyzed by using the SAS software. ANOVA will be used to compare the parameters between groups and the difference between the four 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 2019, recruitment will start. Patients enrollment will be performed between October 2019 to October 2020. All patients should be followed up before December 2023. 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
- 4
- Model description
- Eligible patients will be randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day.
| Arm | Type | Receives |
|---|---|---|
| Intensive blood pressure and cholesterol control | Experimental | Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Drug: Allisartan Isoproxil |
| Intensive blood pressure and routine cholesterol control | Active comparator | Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET, Drug: Allisartan Isoproxil |
| Routine blood pressure and intensive cholesterol control | Active comparator | Drug: Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET |
| Routine blood pressure and cholesterol control | Active comparator | Drug: Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men or women aged over 65 years. patients who never took 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.
- Patient who sign the written consent and are able to go to the clinic by him/herself.
Key exclusion criteria (1 listed)
- suspected or confirmed secondary hypertension; taking two or more antihypertensive drugs; patients who never take antihypertensive drugs with a clinic blood pressure over 180/110 mmHg or treated patients with a clinic blood pressure over 160/100 mmHg or patients with a home blood pressure below 130/80 mmHg; 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 >5.0 mmol/L or <3.5 mmol/L; uncontrolled diabetes (HbA1c >8%); BMI ≥35kg/m²; severe OSAS; 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 |
|---|---|---|
| Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLETamlodipine/atorvastatin (5/20mg tablet) once a day | Drug | Intensive blood pressure and cholesterol control, Routine blood pressure and intensive cholesterol control |
| Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLETamlodipine/atorvastatin (5/10mg tablet) once a day | Drug | Intensive blood pressure and routine cholesterol control, Routine blood pressure and cholesterol control |
| Allisartan Isoproxilallisartan (240mg/tablet) once a day | Drug | Intensive blood pressure and cholesterol control, Intensive blood pressure and routine cholesterol control |
Primary outcome
Combined cardiovascular end-point events
Time frame: 3 years
Fatal and non-fatal stroke, acute MI and cardiovascular death
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 13 Aug 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 Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET, Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET and Allisartan Isoproxil in people with Atrial Fibrillation and 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 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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?
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?
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?
Combined cardiovascular end-point events (time frame: 3 years). 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 13 Aug 2025.