HypertensionPhase 3NCT04668157
A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure
A Phase 3 study testing TAK-536 in people with Hypertension, run by Takeda at 19 sites in Japan.
Trial summary
The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. After this, each participant will take placebo. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Hypertension
- What is being tested?
- TAK-536
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 19 sitesJapan
- Study dates
- 17 May 2021to 28 Dec 2023
- Phase
- Phase 3
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In the opinion of the investigator or subinvestigator, the participant's parent or legal guardian is capable of understanding and complying with protocol requirements.
- The participant's parent or the participant's legal guardian is capable of signing and dating a written informed consent form on behalf of the participant prior to the initiation of any study procedures.
- A Japanese participant who has a diagnosis of hypertension. A participant is eligible if he/she is deemed hypertensive according to the reference blood pressure values of children by gender and age; office sitting diastolic or systolic blood pressure >=95th percentile for essential hypertension without concomitant hypertensive organ damage, and >=90th percentile for secondary hypertension with concomitant CKD, diabetes mellitus, heart failure or hypertensive organ damage.
- In addition, participants need to meet the following criteria:
- If currently treated with any antihypertensive drugs at the start of the Run-in Period: Participant has a documented diagnosis of hypertension and an office sitting diastolic or systolic blood pressure meeting the above criteria at the end of the Run-in Period (Week 0).
- If currently untreated with any antihypertensive drugs at the start of the Run-in Period: Participant meets the above criteria for hypertension on 3 separate time points including screening and the end of the Run-in Period (Week 0). In addition, for a participant with essential hypertension without hypertensive organ damage, the participant does not respond to non-pharmacological therapy such as diet modification or exercises for at least 3 months within 1 year prior to the start of screening.
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- The participant is male or female and aged 2 to less than 6 years at the time of informed consent.
- At screening, the participant has not less than minus 2 standard deviations from mean weight for age of reference population shown in the table of pediatric body weight by the Japanese Society for Pediatric Endocrinology.
- The participant is able to swallow the study drug.
- A participant who has undergone kidney transplantation is eligible if he/she underwent the transplantation, and the graft has been functionally stable (estimated glomerular filtration rate [eGFR] >= 30 mL/min/1.73 m^2) for at least 6 months with evidence (eg, Doppler echography, CT [computed tomography] scan or MRI [magnetic resonance imaging]) excluding dose at least 30 days prior to screening is eligible.
- The participant, judged by the investigator or subinvestigator, who can safely discontinue the therapy with RAS inhibitors for 2 weeks prior to the Treatment Period. This period may change to between 1 and 4 weeks depending on the participant's duration of Run-in Period.
Who cannot join
- The participant has received any investigational compound within 30 days prior to screening or is participating in another clinical study or a post-marketing clinical study.
- Note: This does not apply to participants participating in observational studies without interventional or surgical therapy.
- The participant previously received therapy with azilsartan.
- The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 22 mmHg and/or an office sitting diastolic blood pressure higher by at least 17 mmHg than the 95th percentiles of the reference blood pressure values of children by gender and age.
- The participant has a diagnosis of malignant or accelerated hypertension.
- The participant was noncompliant (compliance: <70% or >130%) with the study drug during the Run-in Period. The proportion of the number of the received the study drug to the number of the study drug which the participants should receive.
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- The participant has severe renal dysfunction (eGFR <30 mL/min/1.73 m^2), is receiving dialysis, has a renovascular disease affecting one or both kidneys, severe nephrotic syndrome not in remission, or a serum albumin level <2.5 g/dL.
- The participant has a history of, or the signs/symptoms of serious cardiovascular, hepatobiliary, gastrointestinal, endocrine (eg, hyperthyroidism, Cushing's syndrome), hematological, immunological, urogenital, psychiatric disease, cancer, or any other disease that adversely affects participant's health, or, in the opinion of the investigator or subinvestigator, potentially confounds the study results.
- The participant has hemodynamically significant left ventricular outflow obstruction due to aortic stenosis or uncorrected aortic valvular disease, or is scheduled to undergo a medical procedure affecting blood pressure during the study (eg, correction of arterial anomaly).
- Note: This does not apply to participants who received medical procedure(s) (eg, surgery for aortic coarctation) before the study and investigator or subinvestigator assess that participant's condition is stable at screening.
- The participant has a history of or concurrent clinically significant abnormality of 12-lead ECG that, in the opinion of the investigator or subinvestigator, disqualifies the participant for participation in the study.
- The participant has poorly controlled diabetes mellitus indicated by HbA1c >9.0% at screening.
- The participant has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level >=2.5 × the upper limit of normal (ULN), or a total bilirubin level >=1.5 × ULN at screening, severely impaired hepatic function, any active liver disease (regardless of the cause), or jaundice.
- The participant has hyperkalemia exceeding ULN at screening.
- The participant has a history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at screening.
- The participant has a known hypersensitivity or allergy to any ARBs.
- The participant needs treatment with any of the excluded medication.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo
Hiroshima Prefectural Hospital
Hiroshima
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken
University of the Ryukyus Hospital
Nakagami-gun, Okinawa
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken
Shiga University of Medical Science Hospital
Ōtsu, Shiga
Kitasato University Hospital
Sagamihara, Kanagawa
Local Independent Administrative Institution Saitama prefectural hospital organization Saitama Children's Medical Center
Saitama
Miyagi Children's Hospital
Sendai, Miyagi
Tohoku University Hospital
Sendai, Miyagi
National Center for Child Health and Development
Setagaya-ku, Tokyo
Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Shimajiri-gun, Okinawa
Jichi Medical University Hospital
Shimotsuke, Tochigi
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo
Shizuoka Childrens Hospital
Shizuoka
Osaka University Hospital
Suita, Osaka
Wakayama Medical University Hospital
Wakayama
About this study
Official title: A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Subjects From 2 to Less Than 6 Years of Age With Hypertension
The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. After this, each participant will take placebo. This might take 2 weeks.
After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks.
After treatment has finished, participants will visit the study clinic for a final check-up.
Read the detailed description
The drug being tested in this study is called TAK-536. TAK-536 is being tested in pediatric participants with hypertension aged 2 to less than 6 years. This study will look at the safety, efficacy, and pharmacokinetics of long-term administration of TAK-536.
The study will enroll 10 participants. Participants will receive the study drug (TAK-536) orally once daily before or after breakfast.
The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the participants do not achieve the target blood pressure and no concerns are found in safety and tolerability.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 56 weeks. Participants will make multiple visits to the clinic.
- Conditions
- Hypertension
- Being tested
- TAK-536
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-536Drug
TAK-536 granule formulation
| Study group | Role | What they receive |
|---|---|---|
| TAK-536 | Experimental | TAK-536 granule formulation, orally once daily before or after breakfast. The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the subjects do not achieve the target blood pressure and no concerns are found in safety and tolerability. Receives: Drug: TAK-536 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant whose parent or legal guardian had signed informed consent form to participate in a study; it did not necessarily have to have a causal relationship with this treatment or study participation. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation whether or not it was considered related to the drug or study procedures. A TEAE was defined as any AE occurring after the start of TAK-536 administration, and until the end of follow-up period of 2 weeks.
Measured: From first dose of study drug up to end of follow-up period (Week 54)
Number of Participants With TEAE Related to Resting 12-lead Electrocardiogram (ECG)
The relatedness of TEAEs with resting 12-lead ECG was based upon investigator discretion.
Measured: From first dose of study drug up to Week 52
Number of Participants With TEAE Related to Anthropometric Measurement
The anthropometric measurements included weight, height and body mass index (BMI). The relatedness of TEAEs to anthropometric measurements was based upon investigator discretion.
Measured: From first dose of study drug up to Week 52
Number of Participants With TEAE Related to Clinical Laboratory Parameters
The laboratory values outside the range (triglycerides greater than [>] 2.5*upper limit of normal [ULN], blood urea nitrogen [BUN] >30 milligram per deciliter [mg/dL], estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter per minute per 1.73 square meter [mL/min/1.73m^2], and glucose <50 mg/dL were considered markedly abnormal for TEAEs. The relatedness of TEAEs to clinical laboratory parameters was based upon investigator discretion.
Measured: From first dose of study drug up to Week 52
Number of Participants With TEAE Related to Vital Sign Values
Vital signs included home sitting blood pressure (diastolic and systolic) and office sitting pulse rate (pulse rate per 1 minute). The pulse rate measured at the last measurement of the sitting blood pressure was used as the sitting pulse rate value. The relatedness of TEAEs to vital signs was based upon investigator discretion.
Measured: From first dose of study drug up to end of follow-up period (Week 54)
Secondary outcomes (4)
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure at Weeks 12 (Last Observation Carried Forward [LOCF]) and 52 (LOCF)
Office trough sitting diastolic blood pressure were measured in a sitting position. LOCF method was used to impute missing values.
Measured: Baseline, Weeks 12 (LOCF) and 52 (LOCF)
Change From Baseline in Office Trough Sitting Systolic Blood Pressure at Weeks 12 (LOCF) and 52 (LOCF)
Office trough sitting systolic blood pressure were measured in a sitting position. LOCF method was used to impute missing values.
Measured: Baseline, Weeks 12 (LOCF) and 52 (LOCF)
Percentage of Participants Who Achieved the Target Blood Pressure at Weeks 12 (LOCF) and 52 (LOCF)
The target blood pressure was defined as the normal reference range for blood pressure by age according to guidelines on the clinical examination for decision making of diagnosis and drug therapy in pediatric participants with cardiovascular diseases by the Japanese Circulation Society 2018 (JCS 2018). LOCF method was used to impute missing values.
Measured: At Weeks 12 (LOCF) and 52 (LOCF)
Plasma Concentration of TAK-536
Plasma concentration of TAK-536 were reported.
Measured: Weeks 2, 4, 8 and 12: Pre-dose and at 2 hours post-dose; Week 16: 2 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start17 May 2021
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
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.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668157
- Sponsor's protocol ID
- Azilsartan-3004
- Other IDs
- U1111-1259-9316, jRCT2041200083
- Status last verified
- Jun 2024
- First submitted
- 10 Dec 2020
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Subjects From 2 to Less Than 6 Years of Age With Hypertension
- ClinicalTrials.gov ID
- NCT04668157
- Acronym / sponsor ID
- Azilsartan-3004
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. After this, each participant will take placebo. This might take 2 weeks.
After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks.
After treatment has finished, participants will visit the study clinic for a final check-up.
Detailed description
The drug being tested in this study is called TAK-536. TAK-536 is being tested in pediatric participants with hypertension aged 2 to less than 6 years. This study will look at the safety, efficacy, and pharmacokinetics of long-term administration of TAK-536.
The study will enroll 10 participants. Participants will receive the study drug (TAK-536) orally once daily before or after breakfast.
The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the participants do not achieve the target blood pressure and no concerns are found in safety and tolerability.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 56 weeks. Participants will make multiple visits to the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-536 | Experimental | Drug: TAK-536TAK-536 granule formulation, orally once daily before or after breakfast. The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the subjects do not achieve the target blood pressure and no concerns are found in safety and tolerability. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- In the opinion of the investigator or subinvestigator, the participant's parent or legal guardian is capable of understanding and complying with protocol requirements.
- The participant's parent or the participant's legal guardian is capable of signing and dating a written informed consent form on behalf of the participant prior to the initiation of any study procedures.
- A Japanese participant who has a diagnosis of hypertension. A participant is eligible if he/she is deemed hypertensive according to the reference blood pressure values of children by gender and age; office sitting diastolic or systolic blood pressure >=95th percentile for essential hypertension without concomitant hypertensive organ damage, and >=90th percentile for secondary hypertension with concomitant CKD, diabetes mellitus, heart failure or hypertensive organ damage.
- If currently treated with any antihypertensive drugs at the start of the Run-in Period: Participant has a documented diagnosis of hypertension and an office sitting diastolic or systolic blood pressure meeting the above criteria at the end of the Run-in Period (Week 0).
- If currently untreated with any antihypertensive drugs at the start of the Run-in Period: Participant meets the above criteria for hypertension on 3 separate time points including screening and the end of the Run-in Period (Week 0). In addition, for a participant with essential hypertension without hypertensive organ damage, the participant does not respond to non-pharmacological therapy such as diet modification or exercises for at least 3 months within 1 year prior to the start of screening.
Key exclusion criteria (17 listed)
- The participant has received any investigational compound within 30 days prior to screening or is participating in another clinical study or a post-marketing clinical study.
- Note: This does not apply to participants participating in observational studies without interventional or surgical therapy.
- The participant previously received therapy with azilsartan.
- The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 22 mmHg and/or an office sitting diastolic blood pressure higher by at least 17 mmHg than the 95th percentiles of the reference blood pressure values of children by gender and age.
- The participant has a diagnosis of malignant or accelerated hypertension.
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 |
|---|---|---|
| TAK-536TAK-536 granule formulation | Drug | TAK-536 |
Primary outcome
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: From first dose of study drug up to end of follow-up period (Week 54)
An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant whose parent or legal guardian had signed informed consent form to participate in a study; it did not necessarily have to have a causal relationship with this treatment or study participation. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation whether or not it was considered related to the drug or study procedures. A TEAE was defined as any AE occurring after the start of TAK-536 administration, and until the end of follow-up period of 2 weeks.
Number of Participants With TEAE Related to Resting 12-lead Electrocardiogram (ECG)
Time frame: From first dose of study drug up to Week 52
The relatedness of TEAEs with resting 12-lead ECG was based upon investigator discretion.
Number of Participants With TEAE Related to Anthropometric Measurement
Time frame: From first dose of study drug up to Week 52
The anthropometric measurements included weight, height and body mass index (BMI). The relatedness of TEAEs to anthropometric measurements was based upon investigator discretion.
Number of Participants With TEAE Related to Clinical Laboratory Parameters
Time frame: From first dose of study drug up to Week 52
The laboratory values outside the range (triglycerides greater than [>] 2.5*upper limit of normal [ULN], blood urea nitrogen [BUN] >30 milligram per deciliter [mg/dL], estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter per minute per 1.73 square meter [mL/min/1.73m^2], and glucose <50 mg/dL were considered markedly abnormal for TEAEs. The relatedness of TEAEs to clinical laboratory parameters was based upon investigator discretion.
Number of Participants With TEAE Related to Vital Sign Values
Time frame: From first dose of study drug up to end of follow-up period (Week 54)
Vital signs included home sitting blood pressure (diastolic and systolic) and office sitting pulse rate (pulse rate per 1 minute). The pulse rate measured at the last measurement of the sitting blood pressure was used as the sitting pulse rate value. The relatedness of TEAEs to vital signs was based upon investigator discretion.
4 secondary outcomes
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure at Weeks 12 (Last Observation Carried Forward [LOCF]) and 52 (LOCF)
Time frame: Baseline, Weeks 12 (LOCF) and 52 (LOCF)
Change From Baseline in Office Trough Sitting Systolic Blood Pressure at Weeks 12 (LOCF) and 52 (LOCF)
Time frame: Baseline, Weeks 12 (LOCF) and 52 (LOCF)
Percentage of Participants Who Achieved the Target Blood Pressure at Weeks 12 (LOCF) and 52 (LOCF)
Time frame: At Weeks 12 (LOCF) and 52 (LOCF)
Plasma Concentration of TAK-536
Time frame: Weeks 2, 4, 8 and 12: Pre-dose and at 2 hours post-dose; Week 16: 2 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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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.
Study Director study director
Takeda
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAK-536 in people with Hypertension, run by Takeda at 19 sites in Japan.
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 11 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Dec 2024). 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?
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE) (time frame: From first dose of study drug up to end of follow-up period (Week 54)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.