Heart FailurePhase 2PRIORITIZE HFNCT03532009
Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
A Phase 2 study testing Sodium Zirconium Cyclosilicate in people with Heart Failure, run by AstraZeneca at 76 sites in 9 countries.
Trial summary
This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sodium Zirconium Cyclosilicate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 76 sitesin 9 countries
- Study dates
- 26 Jun 2018to 22 May 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis. Individuals refusing to provide informed consent for genetic testing may still be included in the study, but will not have to provide samples for genetic analysis.
- Subject must be ≥18 years of age inclusive, at the time of signing the informed consent form.
- Individuals with established documented diagnosis of symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF, NYHA functional class II-IV), which has been present for at least 3 months.
- Individuals with left ventricular ejection fraction ≤ 40% (any measurement made within the past 12 months using echocardiography, multiple gate acquisition scan, computer tomography scanning, magnetic resonance imaging or ventricular angiography is acceptable, provided no subsequent measurement above 40%).
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- Individuals receiving background standard of care for HFrEF and treated according to locally recognized guidelines with both drugs and devices, as appropriate. Therapy with ACEi/ARB/ARNI, MRA and beta blocker should have been stable for ≥4 weeks. Subjects who are not being treated with beta blockers because of a contraindication are eligible. Subjects should be taking no MRA or a low dose of MRA (spironolactone, eplerenone, or canrenone) defined as less than or equal to 12.5 mg once a day (QD) or 25 mg every other day (QOD). If patients are taking a low dose MRA, the rationale for the low dose must be the patient could not tolerate a higher dose due to documented hyperkalemia observed at higher doses.
- Individuals with mild hyperkalaemia or at risk of developing hyperkalaemia during the study, as defined by meeting all of the criteria in any one of the 3 categories listed below:
- eGFR 20-44 ml/min/1.73m2 by CKD-EPI and local lab-K 4.0-5.5 mmol/L inclusive, or
- eGFR 45-59 ml/min/1.73m2 by CKD-EPI and local lab-K 5.1-5.5 mmol/L inclusive, or
- eGFR 45-59 ml/min/1.73m2 by CKD-EPI and local lab-K 4.0-5.0 mmol/L inclusive and a documented history of S-K > 5.0 mmol/L due to RAASi.
- Women of childbearing potential must have a negative pregnancy test during screening (before first dose of IP) performed locally.
Who cannot join
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- Current acute decompensated HF, hospitalization due to decompensated HF within 4 weeks prior to enrolment, or Myocardial infarction (MI), unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
- Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrolment or intent to perform atrial fibrillation ablation or to implant a CRT device.
- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomization.
- Symptomatic bradycardia or second (Mobitz type 2) or third-degree heart block without a pacemaker.
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- Symptomatic hypotension or systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements.
- Receiving dialysis or anticipated by the investigator to require dialysis therapy within 3 months.
- Prior history of hypersensitivity to a RAASi drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification.
- Addison's disease or other causes of hypoaldosteronism.
- Known hypersensitivity to ZS.
- Any condition outside the cardiovascular (CV) and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement.
- Active malignancy requiring treatment.
- MRA therapies that are mainly investigational and/or are not widely available as an oral dosing formulation (eg, canrenoate and finerenone) are excluded.
- Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS;e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®) within 7 days prior to the first dose of study drug.
- Treated with potassium supplements within 7 days prior to randomization.
- Participation in another clinical study with ZS at any time or treatment with any investigational product (IP) during the last 3 months.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, AstraZeneca representatives, and/or staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- Previous randomisation in the present study.
- Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥550 msec.
Trial locations and contacts
76 sites in 9 countries.
76 sites in 9 countries
United States14 sites
Research Site
Alexandria, Louisiana, 71301
Research Site
Boston, Massachusetts, 02115
Research Site
Brooklyn, New York, 11204
Research Site
El Paso, Texas, 79935
Research Site
Flint, Michigan, 48504
Research Site
Indianapolis, Indiana, 46260
Research Site
Miami, Florida, 33133
Research Site
National City, California, 91950
Research Site
New Smyrna Beach, Florida, 32169
Research Site
Port Charlotte, Florida, 33952
Research Site
Rapid City, South Dakota, 57701
Research Site
Stanford, California, 94305
Research Site
Waterbury, Connecticut, 06708
Research Site
Wyomissing, Pennsylvania, 19610
Brazil14 sites
Research Site
Belo Horizonte, 30140 062
Research Site
Belo Horizonte, 30150-240
Research Site
Brasillia, 70200-730
Research Site
Campina Grande do Sul, 83430000
Research Site
Campinas, 13060-080
Research Site
Curitiba, 80010-030
Research Site
Marília, 17515000
Research Site
Porto Alegre, 90020090
Research Site
Rio de Janeiro, 20241-180
Research Site
Santo André, 09090-790
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 05403-000
Research Site
Uberlândia, 38411-186
Research Site
Votuporanga, 15500-003
Hungary12 sites
Research Site
Baja, 6500
Research Site
Budapest, 1051
Research Site
Budapest, 1096
Research Site
Budapest, 1106
Research Site
Budapest, 1122
Research Site
Budapest, 1204
Research Site
Hatvan, 3000
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3529
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7623
Research Site
Szentes, 6600
Russia10 sites
Research Site
Aramil, 624002
Research Site
Krasnoyarsk, 660062
Research Site
Moscow, 121552
Research Site
Novosibirsk, 630055
Research Site
Perm, 614000
Research Site
Ryazan, 390039
Research Site
Saint Petersburg, 191015
Research Site
Tver', 170036
Research Site
Yaroslavl, 150062
Research Site
Yekaterinburg, 620039
Poland6 sites
Research Site
Chorzów, 41-500
Research Site
Gdansk, 80-952
Research Site
Legnica, 59-220
Research Site
Poznan, 60-848
Research Site
Rzeszów, 35-055
Research Site
Tczew, 83-110
Romania6 sites
Research Site
Brasov, 500283
Research Site
Bucharest, 042122
Research Site
Cluj-Napoca, 400001
Research Site
Craiova, 200642
Research Site
Sibiu, 550245
Research Site
Tg Mures, 540143
Bulgaria5 sites
Research Site
Plovdiv, 4003
Research Site
Shumen, 9700
Research Site
Sofia, 1202
Research Site
Sofia, 1407
Research Site
Sofia, 1527
Canada5 sites
Research Site
Montreal, Quebec, H1T 1C8
Research Site
Québec, Quebec, G1V 4G5
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
Research Site
Trois-Rivières, Quebec, G8Z 3R9
Research Site
Vancouver, British Columbia, V5Z 1M9
Slovakia4 sites
Research Site
Brezno, 97742
Research Site
Lučenec, 984 01
Research Site
Prešov, 080 01
Research Site
Svidník, 08901
About this study
Official title: A Phase II, Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicentre, Three Month Duration Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in heart failure patients.
Read the detailed description
Patients with chronic heart failure (NYHA II-IV) and serum potassium > 5.0 mmol/L or at high risk of developing hyperkalaemia will be enrolled. Patients signing informed consent will be screened for up to 14 days. Patients meeting the inclusion criteria, but not the exclusion criteria, are then randomized in a 1:1 ratio to receive ZS or placebo for 3 months while titrating RAASi therapies. Approximately 280 patients will be randomized in the study. Study treatment in this study refers to ZS or placebo, while RAASi therapies are considered background therapy and will not be provided by the study sponsor. Patients will participate in the study for approximately 16 to 18 weeks in total, depending on the duration of the screening period. A Safety Review Committee will be established to review emerging safety data
- Conditions
- Heart Failure
- Being tested
- Sodium Zirconium Cyclosilicate, Placebo
- Keywords
- Heart Failure, Chronic Heart Failure, Hyperkalaemia
- Medical subject headings
- Heart Failure, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium CyclosilicateDrug
Also called ZS; Lokelma
Oral use for approximately 3 months
PlaceboDrug
Also called PBO
Oral use for approximately 3 months
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) | Experimental | Powder for oral suspension Receives: Drug: Sodium Zirconium Cyclosilicate |
| Placebo | Placebo comparator | Powder for oral suspension Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Receiving Different Categories of RAASi Treatments at Month 3
RAASi treatment categories:
- No, or less than target dose, angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB)/ angiotensin receptor/ neprolysin inhibitors (ARNI) and no mineralocorticoid receptor antagonist (MRA);
- ACEi/ARB/ARNI at target dose and no MRA;
- MRA at less than target dose;
- MRA at target dose.
Missing values at 3 months were imputed using a multiple imputation approach with 10000 imputations. The imputation model included RAASi category at 3 months as the outcome variable and the following covariates: RAASi category, local lab-K, eGFR and systolic blood pressure measured at the last visit before the 3 months (starting with the randomisation visit) when all the covariates' data were available.
Measured: At the end of the treatment visit (Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start26 Jun 2018
- Primary completion22 May 2020
- Study completion22 May 2020
Why it stopped: Study stopped early due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Tardif, Principal investigator, Montreal Heart Institute 5000 Belanger Street, Montreal, PQ Canada H1T1C8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532009
- Sponsor's protocol ID
- D9484C00001
- Acronym
- PRIORITIZE HF
- Status last verified
- May 2021
- First submitted
- 29 Mar 2018
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Tardif JC, Rouleau J, Chertow GM, Al-Shurbaji A, Lisovskaja V, Gustavson S, Zhao Y, Bouabdallaoui N, Desai AS, Chernyavskiy A, Evsina M, Merkely B, McMurray JJV, Pfeffer MA. Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure. ESC Heart Fail. 2023 Apr;10(2):1066-1076. doi: 10.1002/ehf2.14268. Epub 2022 Dec 23.
PubMed 36564955
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicentre, Three Month Duration Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure
- ClinicalTrials.gov ID
- NCT03532009
- Acronym / sponsor ID
- PRIORITIZE HF / D9484C00001
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Chronic Heart Failure, Hyperkalaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped early due to the COVID-19 pandemic
- Enrolment
- 182 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in heart failure patients.
Detailed description
Patients with chronic heart failure (NYHA II-IV) and serum potassium > 5.0 mmol/L or at high risk of developing hyperkalaemia will be enrolled. Patients signing informed consent will be screened for up to 14 days. Patients meeting the inclusion criteria, but not the exclusion criteria, are then randomized in a 1:1 ratio to receive ZS or placebo for 3 months while titrating RAASi therapies. Approximately 280 patients will be randomized in the study. Study treatment in this study refers to ZS or placebo, while RAASi therapies are considered background therapy and will not be provided by the study sponsor. Patients will participate in the study for approximately 16 to 18 weeks in total, depending on the duration of the screening period. A Safety Review Committee will be established to review emerging safety data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) | Experimental | Drug: Sodium Zirconium CyclosilicatePowder for oral suspension |
| Placebo | Placebo comparator | Drug: PlaceboPowder for oral suspension |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis. Individuals refusing to provide informed consent for genetic testing may still be included in the study, but will not have to provide samples for genetic analysis.
- Subject must be ≥18 years of age inclusive, at the time of signing the informed consent form.
- Individuals with established documented diagnosis of symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF, NYHA functional class II-IV), which has been present for at least 3 months.
Key exclusion criteria (21 listed)
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- Current acute decompensated HF, hospitalization due to decompensated HF within 4 weeks prior to enrolment, or Myocardial infarction (MI), unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
- Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrolment or intent to perform atrial fibrillation ablation or to implant a CRT device.
- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomization.
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 |
|---|---|---|
| Sodium Zirconium CyclosilicateAlso: ZS; LokelmaOral use for approximately 3 months | Drug | Sodium Zirconium Cyclosilicate (ZS) |
| PlaceboAlso: PBOOral use for approximately 3 months | Drug | Placebo |
Primary outcome
Percentage of Patients Receiving Different Categories of RAASi Treatments at Month 3
Time frame: At the end of the treatment visit (Month 3)
RAASi treatment categories: * No, or less than target dose, angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB)/ angiotensin receptor/ neprolysin inhibitors (ARNI) and no mineralocorticoid receptor antagonist (MRA); * ACEi/ARB/ARNI at target dose and no MRA; * MRA at less than target dose; * MRA at target dose. Missing values at 3 months were imputed using a multiple imputation approach with 10000 imputations. The imputation model included RAASi category at 3 months as the outcome variable and the following covariates: RAASi category, local lab-K, eGFR and systolic blood pressure measured at the last visit before the 3 months (starting with the randomisation visit) when all the covariates' data were available.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36564955Tardif JC, Rouleau J, Chertow GM, Al-Shurbaji A, Lisovskaja V, Gustavson S, Zhao Y, Bouabdallaoui N, Desai AS, Chernyavskiy A, Evsina M, Merkely B, McMurray JJV, Pfeffer MA. Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure. ESC Heart Fail. 2023 Apr;10(2):1066-1076. doi: 10.1002/ehf2.14268. Epub 2022 Dec 23.
- redacted CSR synopsisLink provided by the sponsor.
- redacted SAPLink provided by the sponsor.
- redacted CSPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Jean-Claude Tardif principal investigator
Montreal Heart Institute 5000 Belanger Street, Montreal, PQ Canada H1T1C8
76 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Zirconium Cyclosilicate in people with Heart Failure, run by AstraZeneca at 76 sites in 9 countries.
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 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Brazil, Hungary, Russia, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Receiving Different Categories of RAASi Treatments at Month 3 (time frame: At the end of the treatment visit (Month 3)). 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 NCT03532009, which also lists 1 linked publication.
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 Jun 2021.