Diabetes Mellitus, Type 2Phase 4NCT04978649
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy
A Phase 4 study testing Allisartan Isoproxil and Amlodipine in people with Diabetes Mellitus, Type 2 and Blood Pressure, run by Guangdong Provincial People's Hospital.
Trial summary
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular (CV) and renal events. Diabetic patients with hypertension benefit from BP lowering treatment. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Blood Pressure
- What is being tested?
- Allisartan Isoproxil and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Jul 2028
- 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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy; a glycosylated hemoglobin (HbA1c) ≤ 8.5%;
- informed consent provided and long-term follow-up possible
Who cannot join
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate < 45 ml/min/1.73m2;
- a history of congestive heart failure with left ventricular ejection fraction < 40%, requiring treatment with renin-angiotensin system (RAS) blockers; coronary artery disease requiring RAS blockers for secondary prevention;
Show all 17Show fewer
- acute on-set of stroke within 6 months prior to randomization;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
- a history of primary or secondary renal diesease requiring a therapy using glucocorticoid or immunity inhibitor;
- a history of polycystic kidney;
- known contraindications for the active study medications;
- a history of psychological or mental disorder;
- pregnancy or currently planning to have babies or lactation;
- severe diseases such as severe valvular heart diseases;
- an expected residual life span less than 3 years;
- a malignancy that clinical investigators consider as unsuitable to participate;
- currently participating in another clinical trial.
About this study
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular (CV) and renal events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD-CKD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 5322 patients to be recruited over three years and to be followed up for a median of four years and a half. IPAD-CKD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major renal events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the double-blind study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.
Read the detailed description
The IPAD-CKD trial is a randomized, open-label, parallel-designed, multicenter study. 5322 patients will be recruited over three years with a median follow up of 4.5 years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and < 90 mm Hg diastolic, results in 20% reduction in the incidence of major renal events (the primary endpoint), a composite of renal failure and proteinuria progression. Secondary endpoints of this study include: renal failure ; proteinuria progression; proteinuria reversion; end stage renal disease; cardiovascular-cause mortality; MI; hospitalization for HF; stroke;hospitalization for unstable angina; all-cause mortality;development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer.
Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. For participants in the intensive group, the sitting systolic BP should decrease to < 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary.For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg. Across the whole study, 310 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis at the accumulation of 107 and 214 primary endpoints respectively. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.
- Conditions
- Diabetes Mellitus, Type 2, Blood Pressure
- Being tested
- Allisartan Isoproxil, Amlodipine
- Keywords
- prehypertension, renal disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Prehypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allisartan IsoproxilDrug
Also called Xinlitan
Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
AmlodipineDrug
Also called Qiaohean
Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).
| Study group | Role | What they receive |
|---|---|---|
| intensive treatment group | Active comparator | Real antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication. Receives: Drug: Allisartan Isoproxil; Drug: Amlodipine |
| standard treatment group | Placebo comparator | In this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic. Receives: Drug: Allisartan Isoproxil; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Major Renal Events
The major renal events defined in the study include a composite of renal failure (defined as dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m 2), or serum creatinine level >3.3 mg/dl, or a doubling of the serum creatinine level）and proteinuria progression（defined as:uACR ≥30 mg/gCr if baseline uACR< 30 mg/gCr; uACR ≥300 mg/gCr if baseline uACR is between 30 to 300 mg/gCr.
）
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Secondary outcomes (12)
renal failure
dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m 2), or serum creatinine level >3.3 mg/dl, or a doubling of the serum creatinine level
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
proteinuria progression
uACR ≥30 mg/gCr if baseline uACR< 30 mg/gCr; uACR ≥300 mg/gCr if baseline uACR is between 30 to 300 mg/gCr.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
proteinuria reversion
uACR <30mg/gCr if baseline uACR is between 30 to 300 mg/gCr.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
cardiovascular-cause mortality
Cardiovascular death include death caused by stroke, MI, HF, sudden death or any other death attributed to cardiovascular diseases. Sudden death (ICD-Code I46.1, R96) encompasses any death of unknown origin occurring instantly or within an estimated 24 hours after the onset of acute symptoms as well as unattended death for which no likely cause can be established by autopsy or recent medical history.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Acute Myocardial Infarction
Acute myocardial infarction (MI) is defined when any one of the following criteria occurs. (1) Detection of a rise and/or fall of cardiac biomarker values, with at least one value above the 99th percentile upper reference limit and with at least one of the following manifestations: symptoms of ischaemia that should have lasted for at least 30 minutes and should not have been responsive to sublingual administration of nitrates; new or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB); development of pathological Q waves in the ECG; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. (2) Identification of an intracoronary thrombus by angiography or autopsy. (3) Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Hospitalization of Congestive Heart Failure
Congestive heart failure (HF) requires the presence of three conditions, namely symptoms, such as dyspnea, clinical signs, such as ankle edema or crepitations, and the necessity to initiate treatment with open-label diuretics, vasodilators or antihypertensive drugs. HF cases may also be adjudicated as chronic stable HF but this is not considered an outcome of the present study.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Hospitalization of Unstable Angina
Unstable angina is defined as new onset or worsening angina pectoris requiring hospitalization with angiographically documented coronary atherosclerosis or transient electrocardiographic changes of the ST-segment or T-wave without evidence for myocardial necrosis. This diagnosis excludes patients with angina pectoris admitted to the hospital only for investigation.
Measured: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
All-cause Mortality
All-cause mortality refers to death from any causes.
Measured: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Diabetic Retinopathy Requiring Interventional Operation or Surgery
Diabetic retinopathy requiring interventional operation or surgery is defined as the confirmed diagnosis of diabetic retinopathy, indicated for interventional operation or surgery, which is documented by ophthalmologists.
Measured: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Peripheral Arterial Diseases Requiring Revascularization
Peripheral arterial diseases requiring revascularization are defined as the confirmed diagnosis of any one of the peripheral arterial diseases indicated for revascularization.
Measured: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
New Atrial Fibrillation or Flutter
Atrial fibrillation or flutter is confirmed and documented with electrocardiogram indicating the occurence of atrial fibrillation or flutter. New development of atrial fibrillation or flutter is defined only if a participant at baseline has no history of and his or her electrocardiogram shows no signs of atrial fibrillation or flutter.
Measured: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Cancer
Cancer defined in the present study is recorded only when there is pathologically confirmed evidence.
Measured: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Why it stopped: Cooperation plan has been changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XueQing Yu, Guangdong Provincial People's Hospital
- Investigators
- Xueqing Yu, Doctor, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978649
- Sponsor's protocol ID
- GDPH-IPAD-CKD
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2021
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy
- ClinicalTrials.gov ID
- NCT04978649
- Acronym / sponsor ID
- GDPH-IPAD-CKD
- Conditions
- Diabetes Mellitus, Type 2, Blood Pressure
- Keywords
- prehypertension, renal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cooperation plan has been changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 27 Jul 2021 (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.
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular (CV) and renal events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD-CKD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 5322 patients to be recruited over three years and to be followed up for a median of four years and a half. IPAD-CKD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major renal events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the double-blind study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.
Detailed description
The IPAD-CKD trial is a randomized, open-label, parallel-designed, multicenter study. 5322 patients will be recruited over three years with a median follow up of 4.5 years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and < 90 mm Hg diastolic, results in 20% reduction in the incidence of major renal events (the primary endpoint), a composite of renal failure and proteinuria progression. Secondary endpoints of this study include: renal failure ; proteinuria progression; proteinuria reversion; end stage renal disease; cardiovascular-cause mortality; MI; hospitalization for HF; stroke;hospitalization for unstable angina; all-cause mortality;development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer.
Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. For participants in the intensive group, the sitting systolic BP should decrease to < 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary.For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg. Across the whole study, 310 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis at the accumulation of 107 and 214 primary endpoints respectively. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive treatment group | Active comparator | Drug: Allisartan Isoproxil, Drug: AmlodipineReal antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication. |
| standard treatment group | Placebo comparator | Drug: Allisartan Isoproxil, Drug: AmlodipineIn this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy; a glycosylated hemoglobin (HbA1c) ≤ 8.5%;
- informed consent provided and long-term follow-up possible
Key exclusion criteria (17 listed)
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate < 45 ml/min/1.73m2;
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 |
|---|---|---|
| Allisartan IsoproxilAlso: XinlitanAllisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic. | Drug | intensive treatment group, standard treatment group |
| AmlodipineAlso: QiaoheanAmlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic). | Drug | intensive treatment group, standard treatment group |
Primary outcome
Composite of Major Renal Events
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
The major renal events defined in the study include a composite of renal failure (defined as dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m 2), or serum creatinine level >3.3 mg/dl, or a doubling of the serum creatinine level）and proteinuria progression（defined as:uACR ≥30 mg/gCr if baseline uACR< 30 mg/gCr; uACR ≥300 mg/gCr if baseline uACR is between 30 to 300 mg/gCr. ）
12 secondary outcomes
renal failure
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
proteinuria progression
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
proteinuria reversion
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
cardiovascular-cause mortality
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Acute Myocardial Infarction
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Hospitalization of Congestive Heart Failure
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
Hospitalization of Unstable Angina
Time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months
All-cause Mortality
Time frame: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Diabetic Retinopathy Requiring Interventional Operation or Surgery
Time frame: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Peripheral Arterial Diseases Requiring Revascularization
Time frame: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
New Atrial Fibrillation or Flutter
Time frame: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Cancer
Time frame: Time Frame: From date of randomization until the date of death from any causes, assessed up to 60 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
Xueqing Yu, Doctor study chair
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allisartan Isoproxil and Amlodipine in people with Diabetes Mellitus, Type 2 and Blood Pressure, run by Guangdong Provincial People's Hospital.
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 5 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: withdrawn, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Composite of Major Renal Events (time frame: From date of randomization until the date of first documented incidence of the major renal events prespecified, whichever comes first, assessed up to 60 months). 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 26 Aug 2022.