Pediatric HypertensionPhase 3NCT02791438
A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension
A Phase 3 study testing Azilsartan in people with Pediatric Hypertension, run by Takeda at 30 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety of administration of azilsartan in pediatric patients aged 6 to less than 16 years with hypertension. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Pediatric Hypertension
- What is being tested?
- Azilsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 30 sitesJapan
- Study dates
- 18 Aug 2016to 4 Jun 2019
- 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 6 to 15 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 the participant's 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. Written informed assent is also obtained from the participant as much as possible.
- The 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 ≥ 95 percentile for essential hypertension without concomitant hypertensive organ damage, and ≥ 90 percentile for secondary hypertension with concomitant chronic kidney disease (CKD), diabetes mellitus, heart failure or any 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 historical 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 who meets the above criteria on 3 separate time points including screening and the end of the Run-in Period (Week 0). In addition, participant with essential hypertension without concomitant hypertensive organ damage still maintains hypertension with non-pharmacotherapy including foods 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 6 to less than 16 years at the time of informed consent.
- The participant weighs at least 20 kg at screening.
- The participant is capable of taking the tablets or granules supplied as the study drug.
- A participant who has undergone kidney transplantation is eligible if he/she underwent the transplantation at least 6 months earlier at screening, 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, computed tomography (CT) scan or magnetic resonance imaging (MRI) excluding grafted kidney arterial stenosis. A participant on immunosuppressive therapy with a stable dose at least 30 days prior to screening is eligible.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent through 1 month after the completion of the study, and proves negative in the pregnancy test at screening.
- The participants judged by the investigator or subinvestigator that he/she can discontinue the therapy with renin-angiotensin-system (RAS) inhibitors for 2 weeks (acceptable range, 1 to 4 weeks) in safe prior to the Treatment 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 invasive therapy.
- The participant previously received therapy with azilsartan. Note: This does not apply to participants participating in single dose pharmacokinetic studies of TAK-536.
- The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 15 mmHg and/or an office sitting diastolic blood pressure higher by at least 10 mmHg than the 99 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 (< 70% or > 130%) with the study drug during the Run-in Period.
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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, urinogenital, 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 aortic valvular disease, or is scheduled to undergo a medical procedure affecting blood pressure during the study (eg, correction of arterial anomaly).
- The participant has a history of or concurrent clinically significant abnormality of 12-lead electrocardiogram (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 hemoglobin A1c (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 angiotensin II receptor blocker (ARBs).
- The participant needs treatment with any of the excluded medication.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after the completion of this study.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Study site
Akita
Study site
Chiba
Study site
Fuchū, Tokyo
Study site
Fukuoka
Study site
Fukushima
Study site
Hiroshima
Study site
Izumi, Osaka
Study site
Kanazawa, Ishikawa-ken
Study site
Kobe, Hyōgo
Study site
Nagakute, Aichi-ken
Study site
Nagoya, Aichi-ken
Study site
Nankoku, Kochi
Study site
Nerima-ku, Tokyo
Study site
Niigata
Study site
Ōbu, Aichi-ken
Study site
Okayama
Study site
Osaka
Study site
Ōsaka-sayama, Osaka
Study site
Ōta-ku, Tokyo
Study site
Ōtsu, Shiga
Study site
Saitama
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Setagaya-ku, Tokyo
Study site
Shimajiri-gun, Okinawa
Study site
Shimotsuke, Tochigi
Study site
Shinjuku-ku, Tokyo
Study site
Shizuoka
Study site
Wakayama
Study site
Yokohama, Kanagawa
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 Patients 6 to Less Than 16 Years of Age With Hypertension
The purpose of this study is to evaluate the safety of administration of azilsartan in pediatric patients aged 6 to less than 16 years with hypertension.
Read the detailed description
The drug being tested in this study is called azilsartan. Azilsartan is being tested to treat pediatric participants with hypertension.
The study enrolled 27 participants. Following a 2-week Placebo Run-in Period, participants were assigned to one of the two treatment groups based on weight:
- Azilsartan 2.5 - 20 mg (Participants < 50 kg)
- Azilsartan 5 - 40 mg (Participants ≥ 50 kg)
Participants weighing < 50 kg were asked to take an initial dose azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) and participants weighing ≥ 50 kg were asked to take an initial dose of 5 mg azilsartan (titrated as needed to the highest dose of 40 mg).
This multi-centre trial was conducted in Japan. The overall time to participate in this study is 56 weeks. The study consisted of a Run-in Period (Week -2 to Week 0), a 52-week Treatment Period, and a 2-week Follow-up Period (up to Week 54). Participants made multiple visits to the clinic and a final visit 2 weeks after the last dose of study drug for follow-up assessment.
- Conditions
- Pediatric Hypertension
- Being tested
- Azilsartan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzilsartanDrug
Also called TAK-536, AZILVA ®
Azilsartan granules and tablets
PlaceboDrug
Placebo-matching azilsartan granules and tablets
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Experimental | Following a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg. Receives: Drug: Azilsartan; Drug: Placebo |
| Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | Experimental | Following a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg. Receives: Drug: Azilsartan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Measured: Up to Week 54
Number of Participants With TEAEs Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI))
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Measured: Up to Week 54
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) >30, Creatinine (mg/dL) >2.0, eGFR (mL/min/1.73m^2) <30, Creatine Kinase (U/L) >5×ULN) are considered markedly abnormal.
Measured: Up to Week 54
Number Of Participants With TEAEs Related To Resting 12-Lead Electrocardiogram (ECG)
A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events.
Measured: Up to Week 54
Number Of Participants With TEAEs Related To Vital Signs (Hypotension)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Vital signs included office standing blood pressure, office sitting pulse rate, office standing pulse rate, and home sitting blood pressure. Any abnormal vital signs findings determined by the investigator to be clinically significant were reported as adverse events.
Measured: Up to Week 54
Secondary outcomes (6)
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.
Measured: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52)
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.
Measured: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)
Percentage Of Participants Who Achieve The Target Blood Pressure
Target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012). The data of change from baseline to EOT 1 and EOT 2 were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively. Target blood pressure were described on Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012) (see Links on Registration Section).
Measured: Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)
Observed Plasma Concentration for Azilsartan
Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Measured: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Reported data were observed plasma concentration for Azilsartan Metabolites (M-I) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Measured: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Reported data were observed plasma concentration for Azilsartan Metabolites (M-II) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
Measured: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start18 Aug 2016
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
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 Pediatric 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791438
- Sponsor's protocol ID
- TAK-536/OCT-101
- Other IDs
- U1111-1182-4241, JapicCTI-163260
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2016
- Last updated
- 7 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. 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 Patients 6 to Less Than 16 Years of Age With Hypertension
- ClinicalTrials.gov ID
- NCT02791438
- Acronym / sponsor ID
- TAK-536/OCT-101
- Conditions
- Pediatric Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of administration of azilsartan in pediatric patients aged 6 to less than 16 years with hypertension.
Detailed description
The drug being tested in this study is called azilsartan. Azilsartan is being tested to treat pediatric participants with hypertension.
The study enrolled 27 participants. Following a 2-week Placebo Run-in Period, participants were assigned to one of the two treatment groups based on weight:
- Azilsartan 2.5 - 20 mg (Participants < 50 kg)
- Azilsartan 5 - 40 mg (Participants ≥ 50 kg)
Participants weighing < 50 kg were asked to take an initial dose azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) and participants weighing ≥ 50 kg were asked to take an initial dose of 5 mg azilsartan (titrated as needed to the highest dose of 40 mg).
This multi-centre trial was conducted in Japan. The overall time to participate in this study is 56 weeks. The study consisted of a Run-in Period (Week -2 to Week 0), a 52-week Treatment Period, and a 2-week Follow-up Period (up to Week 54). Participants made multiple visits to the clinic and a final visit 2 weeks after the last dose of study drug for follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Experimental | Drug: Azilsartan, Drug: PlaceboFollowing a 2-week placebo run-in period, azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) was administered orally once daily before or after breakfast, for the participants weighing < 50 kg. |
| Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | Experimental | Drug: Azilsartan, Drug: PlaceboFollowing a 2-week placebo run-in period, azilsartan 5 mg (titrated as needed to the highest dose of 40 mg) was administered orally once daily before or after breakfast, for the participants weighing ≥ 50 kg. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- In the opinion of the investigator or subinvestigator, the participant's parent or the participant's 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. Written informed assent is also obtained from the participant as much as possible.
- The 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 ≥ 95 percentile for essential hypertension without concomitant hypertensive organ damage, and ≥ 90 percentile for secondary hypertension with concomitant chronic kidney disease (CKD), diabetes mellitus, heart failure or any hypertensive organ damage.
- The participant is male or female and aged 6 to less than 16 years at the time of informed consent.
- The participant weighs at least 20 kg at 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 invasive therapy.
- The participant previously received therapy with azilsartan. Note: This does not apply to participants participating in single dose pharmacokinetic studies of TAK-536.
- The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 15 mmHg and/or an office sitting diastolic blood pressure higher by at least 10 mmHg than the 99 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 |
|---|---|---|
| AzilsartanAlso: TAK-536, AZILVA ®Azilsartan granules and tablets | Drug | Azilsartan 2.5 - 20 mg (Weight < 50 kg), Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
| PlaceboPlacebo-matching azilsartan granules and tablets | Drug | Azilsartan 2.5 - 20 mg (Weight < 50 kg), Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 54
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Number of Participants With TEAEs Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI))
Time frame: Up to Week 54
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Number Of Participants With Markedly Abnormal Values of Laboratory Parameters
Time frame: Up to Week 54
The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) >30, Creatinine (mg/dL) >2.0, eGFR (mL/min/1.73m^2) <30, Creatine Kinase (U/L) >5×ULN) are considered markedly abnormal.
Number Of Participants With TEAEs Related To Resting 12-Lead Electrocardiogram (ECG)
Time frame: Up to Week 54
A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events.
Number Of Participants With TEAEs Related To Vital Signs (Hypotension)
Time frame: Up to Week 54
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Vital signs included office standing blood pressure, office sitting pulse rate, office standing pulse rate, and home sitting blood pressure. Any abnormal vital signs findings determined by the investigator to be clinically significant were reported as adverse events.
6 secondary outcomes
Change From Baseline in Office Trough Sitting Systolic Blood Pressure
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52)
Change From Baseline in Office Trough Sitting Diastolic Blood Pressure
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)
Percentage Of Participants Who Achieve The Target Blood Pressure
Time frame: Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)
Observed Plasma Concentration for Azilsartan
Time frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Observed Plasma Concentration for Azilsartan Metabolites (M-I)
Time frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Observed Plasma Concentration for Azilsartan Metabolites (M-II)
Time frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 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 Azilsartan in people with Pediatric Hypertension, run by Takeda at 30 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 12 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 23 Dec 2019). 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 Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 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 7 Feb 2020.