Aortic StenosisPhase 4NCT03666351
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
A Phase 4 study testing Amlodipine 5mg, Losartan and Losartan and Amlodipine in people with Aortic Stenosis and Aortic Regurgitation, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Aortic Stenosis, Aortic Regurgitation, Hypertension
- What is being tested?
- Amlodipine 5mg, Losartan and Losartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2018to 25 Jul 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 19 years and < 80 years
- Diagnosis of mild-moderate AS or mild-moderate AR
- Applicable to 2.0~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2~0.6 cm of Vena contracta for mild-moderate AR
- Diagnosis of hypertension (SBP > 130 mmHg if being treated or SBP > 140 mmHg if being untreated)
- For females of childbearing potential; negative pregnancy test results during the screening period and prior to administration of the investigational product, and agreement on use of medically allowable contraceptive measures (condom, oral contraceptive pills, injectable or implantable contraceptives, intrauterine devices, birth control patches, etc.) during the study period
- Voluntary written consent to taking part in the clinical study and willingness to comply with requirements of the study
Who cannot join
- History of a cardiac valve replacement surgery (replacement surgery of mitral valve, aortic valve or tricuspid valve)
- Accompanied by severe mitral regurgitation
- Admitted to needing a surgery by the current treatment guidelines
- Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc.
- < 50% of left ventricular ejection fraction
- History of hypersensitivity reaction to active ingredients of the investigational product (Amlodipine, Losartan and Chlorthalidone), dihydropyridine derivatives, thiazide drugs and other sulfonamide derivatives or their compositions
Show all 25Show fewer
- Pregnant or breastfeeding
- Symptomatic orthostatic hypotension
- Severe liver failure or renal failure (< 30 mL/min of creatinine clearance)
- Hereditary angioedema or history of angioedema at treatment with ACE inhibitors or angiotensin II receptor blockers
- Primary hyperaldosteronism
- Genetic problems such as galactose intolerance, Lapp Lapp lactase deficiency or glucose-galactose malabsorption
- Anuria
- Refractory hypokalemia
- Hyponatremia or hypercalcemia
- Symptomatic hyperuricemia (history of gout or uric acid lithiasis)
- Untreated Addison's disease
- Appropriately uncontrolled diabetes
- Congenital or incurable hypertension
- Diagnosis of severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.) within six months prior to the date of ICF obtainment
- Wasting disease, autoimmune disease or connective tissue disease
- Diagnosis of malignant tumor within five years prior to the date of ICF obtainment
- Administration of another investigational product within four weeks prior to the date of ICF obtainment
- For a patient who is taking anticoagulants and thrombolytic agents; considered difficult to keep a stable dosage/regimen by the investigator.
- Considered unsuitable to be a subject by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
Read the detailed description
1.Primary objectives
- To evaluate changes from baseline in LVM at V5 (24M)
2.Secondary objectives
- To evaluate changes from baseline in LV global longitudinal strain at V5 (24M)
- To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at V5 (24M)
- To evaluate changes from baseline in LV volumes, a stroke volume index and LV ejection fraction at V5 (24M)
- To evaluate a rate of disease progression
- In case of Aortic stenosis (AS), to evaluate changes from baseline in Aortic Valve Area (AVA), Vmax, Mean Pressure Gradient (PG) and Valvulo-arterial impedance (Zva) at V5 (24M)
- In case of Aortic regurgitation (AR), to evaluate changes from baseline in Vena contracta at V5 (24M)
- To evaluate changes from baseline in blood pressure at V2(6M), V3(12M), V4(18M) and V5(24M)
- To evaluate a cumulative incidence rate for each visit time point
- Death, Cardiovascular(CV) death, Heart Failure(HF), Myocardial Infarction(MI), Hospitalization, Aortic Valve Replacement(AVR)
- To evaluate outcomes of adverse events, physical examination, vital signs (pulse) and laboratory tests (hematological examination, blood biochemical examination, urine test and pregnancy test)
- Being tested
- Amlodipine 5mg, Losartan, Losartan and Amlodipine, Amlodipine/Losartan/Chlorthalidone, current treatment
- Keywords
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM, Left Ventricular Hypertrophy
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 5mgDrug
Also called Amodipin Tab.
Amlodipine 5 mg
LosartanDrug
Also called Osartan Tab. 50 mg
Losartan Potassium 50 mg
Losartan and AmlodipineDrug
Also called Amosartan Tab. 5/50 mg, Amosartan Tab. 5/100 mg
Amlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg
Amlodipine/Losartan/ChlorthalidoneDrug
Also called Amosartan Plus Tab. 5/100/12.5 mg
Amlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg
current treatmentDrug
treatment is done by maintaining the current treatment
| Study group | Role | What they receive |
|---|---|---|
| The intensive care group | Experimental | The intensive care group is targeted at ≤ 130 mmHg of systolic blood pressure, and treatment is done by changing the current treatment to the investigational product.
In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -> Losartan and Amlodipine 5/50 mg -> Losartan and Amlodipine 5/100 mg -> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition. Receives: Drug: Amlodipine 5mg; Drug: Losartan; Drug: Losartan and Amlodipine; Drug: Amlodipine/Losartan/Chlorthalidone |
| The usual care group | Experimental | The usual care group is targeted at ≤ 140 mmHg of systolic blood pressure, and treatment is done by maintaining the current treatment, adding the investigational product, or changing the current treatment to the investigational product.
In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -> Losartan and Amlodipine 5/50 mg -> Losartan and Amlodipine 5/100 mg -> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition. Receives: Drug: Amlodipine 5mg; Drug: Losartan; Drug: Losartan and Amlodipine; Drug: Amlodipine/Losartan/Chlorthalidone; Drug: current treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate changes from baseline in Left Ventricular Mass at 24M
To evaluate changes from baseline in Left Ventricular Mass at 24M
Measured: 24 months
Secondary outcomes (8)
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Measured: 24 months
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Measured: 24 months
Changes from baseline in Left Ventricular volumes at 24M
Changes from baseline in Left Ventricular volumes at 24M
Measured: 24 months
Rate of disease progression
- In case of Aortic Stenosis, to evaluate changes from baseline in Aortic Valve Area, tricuspid regurgitation velocity, Mean Pressure Gradient and Valvulo-arterial impedance at 24M
- In case of Aortic Regurgitation, to evaluate changes from baseline in Vena contracta at 24M
Measured: 24 months
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
Measured: 6 months, 12 months, 18 months, 24 months
Cumulative incidence rate for each visit time point
Cumulative incidence rate for each visit time point
- Death, Cardiovascular death, Heart Failure, Myocardial Infarction, Hospitalization, Aortic Valve Replacement
Measured: 6 months, 12 months, 18 months, 24 months
Changes from baseline in stroke volume index at 24M
Changes from baseline in stroke volume index at 24M
Measured: 24 months
Changes from baseline in Left Ventricular ejection fraction at 24M
Changes from baseline in Left Ventricular ejection fraction at 24M
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start18 Oct 2018
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- A prospective, multicentre, randomized, open label, evaluator-blind study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duk-Hyun Kang, Principal investigator, 10 institutions including Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666351
- Sponsor's protocol ID
- HM_AMO_401
- Status last verified
- Sep 2022
- First submitted
- 20 Aug 2018
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data
Publications
Kim M, Choi JH, Kim HK, Kim HL, Shin SH, Jang JY, Park JH, Kim KH, Hong GR, Park SM, Lee SA, Kang DH. Effects of intensive blood pressure control on left ventricular hypertrophy in aortic valve disease. Am Heart J. 2024 Feb;268:45-52. doi: 10.1016/j.ahj.2023.11.012. Epub 2023 Nov 23.
PubMed 38006908Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
PubMed 32905623
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT03666351
- Acronym / sponsor ID
- HM_AMO_401
- Keywords
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM, Left Ventricular Hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 11 Sep 2018 (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.
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
Detailed description
1.Primary objectives
- To evaluate changes from baseline in LVM at V5 (24M)
2.Secondary objectives
- To evaluate changes from baseline in LV global longitudinal strain at V5 (24M)
- To evaluate changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at V5 (24M)
- To evaluate changes from baseline in LV volumes, a stroke volume index and LV ejection fraction at V5 (24M)
- To evaluate a rate of disease progression
- In case of Aortic stenosis (AS), to evaluate changes from baseline in Aortic Valve Area (AVA), Vmax, Mean Pressure Gradient (PG) and Valvulo-arterial impedance (Zva) at V5 (24M)
- In case of Aortic regurgitation (AR), to evaluate changes from baseline in Vena contracta at V5 (24M)
- To evaluate changes from baseline in blood pressure at V2(6M), V3(12M), V4(18M) and V5(24M)
- To evaluate a cumulative incidence rate for each visit time point
- Death, Cardiovascular(CV) death, Heart Failure(HF), Myocardial Infarction(MI), Hospitalization, Aortic Valve Replacement(AVR)
- To evaluate outcomes of adverse events, physical examination, vital signs (pulse) and laboratory tests (hematological examination, blood biochemical examination, urine test and pregnancy test)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multicentre, randomized, open label, evaluator-blind study
| Arm | Type | Receives |
|---|---|---|
| The intensive care group | Experimental | Drug: Amlodipine 5mg, Drug: Losartan, Drug: Losartan and Amlodipine, Drug: Amlodipine/Losartan/ChlorthalidoneThe intensive care group is targeted at ≤ 130 mmHg of systolic blood pressure, and treatment is done by changing the current treatment to the investigational product. In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -> Losartan and Amlodipine 5/50 mg -> Losartan and Amlodipine 5/100 mg -> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition. |
| The usual care group | Experimental | Drug: Amlodipine 5mg, Drug: Losartan, Drug: Losartan and Amlodipine, Drug: Amlodipine/Losartan/Chlorthalidone, Drug: current treatmentThe usual care group is targeted at ≤ 140 mmHg of systolic blood pressure, and treatment is done by maintaining the current treatment, adding the investigational product, or changing the current treatment to the investigational product. In case of treatment with the investigational product (IP), the IP titration period is total six months. According to an IP titration scheme(Amlodipine 5 mg or Losartan 50 mg -> Losartan and Amlodipine 5/50 mg -> Losartan and Amlodipine 5/100 mg -> Amlodipine/Losartan/Chlorthalidone 5/100/12.5 mg), IP is successively modified until the target blood pressure is reached, and IP will remain the same after the target blood pressure scope for each group is reached. An IP titration interval is decided by the investigator depending on the subject's condition. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥ 19 years and < 80 years
- Diagnosis of mild-moderate AS or mild-moderate AR
- Applicable to 2.0~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2~0.6 cm of Vena contracta for mild-moderate AR
- Diagnosis of hypertension (SBP > 130 mmHg if being treated or SBP > 140 mmHg if being untreated)
- For females of childbearing potential; negative pregnancy test results during the screening period and prior to administration of the investigational product, and agreement on use of medically allowable contraceptive measures (condom, oral contraceptive pills, injectable or implantable contraceptives, intrauterine devices, birth control patches, etc.) during the study period
Key exclusion criteria (25 listed)
- History of a cardiac valve replacement surgery (replacement surgery of mitral valve, aortic valve or tricuspid valve)
- Accompanied by severe mitral regurgitation
- Admitted to needing a surgery by the current treatment guidelines
- Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc.
- < 50% of left ventricular ejection fraction
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 5mgAlso: Amodipin Tab.Amlodipine 5 mg | Drug | The intensive care group, The usual care group |
| LosartanAlso: Osartan Tab. 50 mgLosartan Potassium 50 mg | Drug | The intensive care group, The usual care group |
| Losartan and AmlodipineAlso: Amosartan Tab. 5/50 mg, Amosartan Tab. 5/100 mgAmlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg | Drug | The intensive care group, The usual care group |
| Amlodipine/Losartan/ChlorthalidoneAlso: Amosartan Plus Tab. 5/100/12.5 mgAmlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg | Drug | The intensive care group, The usual care group |
| current treatmenttreatment is done by maintaining the current treatment | Drug | The usual care group |
Primary outcome
To evaluate changes from baseline in Left Ventricular Mass at 24M
Time frame: 24 months
To evaluate changes from baseline in Left Ventricular Mass at 24M
8 secondary outcomes
Changes from baseline in Left Ventricular global longitudinal strain at 24M
Time frame: 24 months
Changes from baseline in E/E' (E: early diastolic LV inflow velocity, E': early diastolic mitral annulus velocity) at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular volumes at 24M
Time frame: 24 months
Rate of disease progression
Time frame: 24 months
To evaluate changes from baseline in systolic blood pressure at 6M, 12M, 18M, 24M
Time frame: 6 months, 12 months, 18 months, 24 months
Cumulative incidence rate for each visit time point
Time frame: 6 months, 12 months, 18 months, 24 months
Changes from baseline in stroke volume index at 24M
Time frame: 24 months
Changes from baseline in Left Ventricular ejection fraction at 24M
Time frame: 24 months
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 15 Sep 2022.
- Derived from this study: PubMed 38006908Kim M, Choi JH, Kim HK, Kim HL, Shin SH, Jang JY, Park JH, Kim KH, Hong GR, Park SM, Lee SA, Kang DH. Effects of intensive blood pressure control on left ventricular hypertrophy in aortic valve disease. Am Heart J. 2024 Feb;268:45-52. doi: 10.1016/j.ahj.2023.11.012. Epub 2023 Nov 23.
- Derived from this study: PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Derived from this study: PubMed 32905623Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data
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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.
Duk-Hyun Kang principal investigator
10 institutions including Asan Medical Center
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 5mg, Losartan and Losartan and Amlodipine in people with Aortic Stenosis and Aortic Regurgitation, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 6 inclusion and 25 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 15 Sep 2022. 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 South Korea. 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?
To evaluate changes from baseline in Left Ventricular Mass at 24M (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666351, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.