A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Azilsartan 2.5 - 20 mg (Weight < 50 kg) 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. |
Drug: Azilsartan
Azilsartan granules and tablets
Other Names:
Drug: Placebo
Placebo-matching azilsartan granules and tablets
|
| Experimental: Azilsartan 5 - 40 mg (Weight ≥ 50 kg) 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. |
Drug: Azilsartan
Azilsartan granules and tablets
Other Names:
Drug: Placebo
Placebo-matching azilsartan granules and tablets
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [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)) [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 [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) [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) [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.
Secondary Outcome Measures
- Change From Baseline in Office Trough Sitting Systolic Blood Pressure [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)]
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.
- Change From Baseline in Office Trough Sitting Diastolic Blood Pressure [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)]
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.
- Percentage Of Participants Who Achieve The Target Blood Pressure [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)]
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).
- Observed Plasma Concentration for Azilsartan [Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16]
Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.
- Observed Plasma Concentration for Azilsartan Metabolites (M-I) [Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16]
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.
- Observed Plasma Concentration for Azilsartan Metabolites (M-II) [Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
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.
Exclusion Criteria:
- 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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nagakute | Aichi | Japan | ||
| 2 | Nagoya | Aichi | Japan | ||
| 3 | Obu | Aichi | Japan | ||
| 4 | Sapporo | Hokkaido | Japan | ||
| 5 | Kobe | Hyogo | Japan | ||
| 6 | Kanazawa | Ishikawa | Japan | ||
| 7 | Yokohama | Kanagawa | Japan | ||
| 8 | Nankoku | Kochi | Japan | ||
| 9 | Sendai | Miyagi | Japan | ||
| 10 | Shimajiri-gun | Okinawa | Japan | ||
| 11 | Izumi | Osaka | Japan | ||
| 12 | Osaka Sayama | Osaka | Japan | ||
| 13 | Otsu | Shiga | Japan | ||
| 14 | Shimotsuke | Tochigi | Japan | ||
| 15 | Fuchu | Tokyo | Japan | ||
| 16 | Nerima-ku | Tokyo | Japan | ||
| 17 | Ota-ku | Tokyo | Japan | ||
| 18 | Setagaya-ku | Tokyo | Japan | ||
| 19 | Shinjuku-ku | Tokyo | Japan | ||
| 20 | Akita | Japan | |||
| 21 | Chiba | Japan | |||
| 22 | Fukuoka | Japan | |||
| 23 | Fukushima | Japan | |||
| 24 | Hiroshima | Japan | |||
| 25 | Niigata | Japan | |||
| 26 | Okayama | Japan | |||
| 27 | Osaka | Japan | |||
| 28 | Saitama | Japan | |||
| 29 | Shizuoka | Japan | |||
| 30 | Wakayama | Japan |
Sponsors and Collaborators
- Takeda
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- TAK-536/OCT-101
- U1111-1182-4241
- JapicCTI-163260
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 17 investigative sites in Japan from 18 August 2016 to 04 June 2019. |
|---|---|
| Pre-assignment Detail | Following a placebo run-in period, pediatric patients with hypertension received azilsartan at starting doses of 2.5 mg for patients < 50 kilograms (kg) and 5 mg for patients ≥ 50 kg. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Run-In Period | ||
| STARTED | 22 | 5 |
| COMPLETED | 22 | 5 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Run-In Period | ||
| STARTED | 22 | 5 |
| COMPLETED | 19 | 4 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 22 | 5 | 27 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.0
(2.54)
|
12.8
(2.49)
|
9.7
(2.91)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
40.9%
|
1
20%
|
10
37%
|
| Male |
13
59.1%
|
4
80%
|
17
63%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (Count of Participants) | |||
| Japan |
22
100%
|
5
100%
|
27
100%
|
| Height (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
128.4
(10.92)
|
160.4
(16.30)
|
134.3
(17.26)
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
31.94
(8.306)
|
63.78
(10.139)
|
37.83
(15.180)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
19.29
(4.216)
|
24.86
(2.726)
|
20.32
(4.513)
|
| Disease Duration (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
2.30
(2.152)
|
1.66
(2.418)
|
2.18
(2.168)
|
| Office Sitting Blood Pressure (Systolic) at Week 0 (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
123.2
(12.55)
|
136.6
(8.32)
|
125.7
(12.89)
|
| Office Sitting Blood Pressure (Diastolic) at Week 0 (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
72.1
(14.01)
|
71.6
(11.87)
|
72.0
(13.43)
|
| Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mL/min/1.73m^2] |
99.571
(30.9858)
|
131.438
(26.1758)
|
105.472
(32.2493)
|
Outcome Measures
| Title | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
|---|---|
| Description | 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. |
| Time Frame | Up to Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Count of Participants [Participants] |
19
86.4%
|
5
100%
|
| Title | Number of Participants With TEAEs Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI)) |
|---|---|
| Description | 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. |
| Time Frame | Up to Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number Of Participants With Markedly Abnormal Values of Laboratory Parameters |
|---|---|
| Description | 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. |
| Time Frame | Up to Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Blood Urea Nitrogen (BUN) (mg/dL) >30 |
2
9.1%
|
1
20%
|
| Creatinine (mg/dL) >2.0 |
1
4.5%
|
0
0%
|
| eGFR (mL/min/1.73m^2) <30 |
1
4.5%
|
0
0%
|
| Creatine Kinase (U/L) >5×ULN |
0
0%
|
1
20%
|
| Title | Number Of Participants With TEAEs Related To Resting 12-Lead Electrocardiogram (ECG) |
|---|---|
| Description | 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. |
| Time Frame | Up to Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number Of Participants With TEAEs Related To Vital Signs (Hypotension) |
|---|---|
| Description | 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. |
| Time Frame | Up to Week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Count of Participants [Participants] |
1
4.5%
|
0
0%
|
| Title | Change From Baseline in Office Trough Sitting Systolic Blood Pressure |
|---|---|
| Description | 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. |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Change from Baseline at Week 2 |
-7.8
(11.34)
|
-7.4
(5.68)
|
| Change from Baseline at Week 4 |
-10.7
(12.64)
|
-13.2
(11.43)
|
| Change from Baseline at Week 8 |
-10.1
(10.41)
|
-13.0
(10.12)
|
| Change from Baseline at Week 12 |
-13.0
(10.30)
|
-7.6
(10.21)
|
| Change from Baseline at Week 16 |
-13.1
(12.61)
|
-17.6
(6.58)
|
| Change from Baseline at Week 20 |
-10.0
(11.23)
|
-16.6
(11.22)
|
| Change from Baseline at Week 24 |
-12.9
(13.95)
|
-9.4
(11.97)
|
| Change from Baseline at Week 32 |
-13.6
(16.29)
|
-15.3
(10.90)
|
| Change from Baseline at Week 40 |
-10.3
(14.32)
|
-17.5
(12.61)
|
| Change from Baseline (BL) at Week 52 |
-8.9
(12.29)
|
-17.5
(8.89)
|
| Change from BL at Week 54 Follow-up |
-4.4
(12.65)
|
-14.5
(2.12)
|
| Change from BL at EOT 1 (Up to Week 12) |
-13.5
(10.27)
|
-7.6
(10.21)
|
| Change from BL at EOT 2 (Up to Week 52) |
-8.8
(11.79)
|
-15.4
(9.02)
|
| Title | Change From Baseline in Office Trough Sitting Diastolic Blood Pressure |
|---|---|
| Description | 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. |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Change from Baseline at Week 2 |
-7.5
(11.81)
|
-9.8
(5.63)
|
| Change from Baseline at Week 4 |
-11.5
(14.11)
|
-11.2
(10.21)
|
| Change from Baseline at Week 8 |
-11.8
(13.06)
|
-11.6
(11.01)
|
| Change from Baseline at Week 12 |
-14.0
(13.30)
|
-10.0
(10.77)
|
| Change from Baseline at Week 16 |
-13.4
(13.79)
|
-16.6
(8.08)
|
| Change from Baseline at Week 20 |
-13.5
(13.87)
|
-13.8
(9.78)
|
| Change from Baseline at Week 24 |
-14.1
(16.04)
|
-10.8
(7.79)
|
| Change from Baseline at Week 32 |
-11.4
(15.51)
|
-15.8
(15.90)
|
| Change from Baseline at Week 40 |
-11.2
(16.47)
|
-12.0
(11.69)
|
| Change from Baseline (BL) at Week 52 |
-10.7
(14.50)
|
-15.3
(10.81)
|
| Change from BL at Week 54 Follow-up |
-6.1
(9.97)
|
-14.0
(5.66)
|
| Change from BL at EOT I (Up to Week 12) |
-14.8
(13.80)
|
-10.0
(10.77)
|
| Change from BL at EOT 2 (Up to Week 52) |
-10.3
(13.97)
|
-13.6
(10.06)
|
| Title | Percentage Of Participants Who Achieve The Target Blood Pressure |
|---|---|
| Description | 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). |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Week 2 |
45.5
206.8%
|
40.0
800%
|
| Week 4 |
45.5
206.8%
|
20.0
400%
|
| Week 8 |
50.0
227.3%
|
60.0
1200%
|
| Week 12 |
73.7
335%
|
40.0
800%
|
| Week 16 |
66.7
303.2%
|
40.0
800%
|
| Week 20 |
57.1
259.5%
|
40.0
800%
|
| Week 24 |
50.0
227.3%
|
20.0
400%
|
| Week 32 |
50.0
227.3%
|
75.0
1500%
|
| Week 40 |
45.0
204.5%
|
75.0
1500%
|
| Week 52 |
36.8
167.3%
|
75.0
1500%
|
| Week 54 (Follow-up) |
41.2
187.3%
|
50.0
1000%
|
| EOT 1 (Up to Week 12) |
68.2
310%
|
40.0
800%
|
| EOT 2 (Up to Week 52) |
36.4
165.5%
|
60.0
1200%
|
| Title | Observed Plasma Concentration for Azilsartan |
|---|---|
| Description | Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants. |
| Time Frame | Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Week 2 (Predose) |
22.3
(18.64)
|
16.8
(10.50)
|
| Week 2 (Postdose) |
206.0
(157.18)
|
610.0
(12.73)
|
| Week 4 (Predose) |
31.1
(23.35)
|
35.0
(19.66)
|
| Week 4 (Postdose) |
175.0
(125.87)
|
64.0
(NA)
|
| Week 8 (Predose) |
49.2
(60.74)
|
58.0
(31.65)
|
| Week 8 (Postdose) |
221.5
(177.48)
|
587.0
(NA)
|
| Week 12 (Predose) |
48.9
(55.01)
|
64.8
(37.83)
|
| Week 12 (Postdose) |
802.0
(NA)
|
116.0
(NA)
|
| Week 16 (Postdose) |
743.1
(590.29)
|
1675.8
(1579.32)
|
| Title | Observed Plasma Concentration for Azilsartan Metabolites (M-I) |
|---|---|
| Description | 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. |
| Time Frame | Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Week 2 (Predose) |
1.9
(2.15)
|
1.4
(1.14)
|
| Week 2 (Postdose) |
16.3
(9.54)
|
21.0
(1.41)
|
| Week 4 (Predose) |
2.7
(2.92)
|
3.3
(2.63)
|
| Week 4 (Postdose) |
6.5
(6.36)
|
4.0
(NA)
|
| Week 8 (Predose) |
3.1
(3.33)
|
3.8
(2.36)
|
| Week 8 (Postdose) |
37.5
(21.92)
|
25.0
(NA)
|
| Week 12 (Predose) |
3.6
(3.36)
|
7.5
(5.69)
|
| Week 12 (Postdose) |
51.0
(NA)
|
4.0
(NA)
|
| Week 16 (Postdose) |
39.2
(30.60)
|
59.8
(40.07)
|
| Title | Observed Plasma Concentration for Azilsartan Metabolites (M-II) |
|---|---|
| Description | 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. |
| Time Frame | Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure. |
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 22 | 5 |
| Week 2 (Predose) |
53.3
(61.31)
|
41.4
(28.66)
|
| Week 2 (Postdose) |
158.3
(102.88)
|
129.0
(26.87)
|
| Week 4 (Predose) |
71.1
(77.05)
|
90.8
(40.99)
|
| Week 4 (Postdose) |
186.0
(214.96)
|
69
(NA)
|
| Week 8 (Predose) |
113.8
(140.23)
|
124.0
(78.25)
|
| Week 8 (Postdose) |
175.5
(78.49)
|
110.0
(NA)
|
| Week 12 (Predose) |
106.2
(144.85)
|
180.0
(147.97)
|
| Week 12 (Postdose) |
184.0
(NA)
|
86.0
(NA)
|
| Week 16 (Postdose) |
311.0
(480.62)
|
423.6
(277.62)
|
Adverse Events
| Time Frame | From the first dose of study drug up to last dose of study drug plus 2 weeks (up to 62 Weeks) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population (SAF) includes all randomized participants who received at least 1 dose of study medication in treatment period. | |||
| Arm/Group Title | Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/5 (0%) | ||
Serious Adverse Events |
||||
| Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/22 (9.1%) | 0/5 (0%) | ||
| Immune system disorders | ||||
| Kidney transplant rejection | 1/22 (4.5%) | 0/5 (0%) | ||
| Infections and infestations | ||||
| Varicella | 1/22 (4.5%) | 0/5 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Complications of transplanted kidney | 1/22 (4.5%) | 0/5 (0%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/22 (4.5%) | 0/5 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Azilsartan 2.5 - 20 mg (Weight < 50 kg) | Azilsartan 5 - 40 mg (Weight ≥ 50 kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/22 (86.4%) | 5/5 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/22 (4.5%) | 0/5 (0%) | ||
| Leukopenia | 1/22 (4.5%) | 0/5 (0%) | ||
| Nephrogenic anaemia | 1/22 (4.5%) | 0/5 (0%) | ||
| Eye disorders | ||||
| Dry eye | 1/22 (4.5%) | 0/5 (0%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 3/22 (13.6%) | 1/5 (20%) | ||
| Abdominal pain | 3/22 (13.6%) | 0/5 (0%) | ||
| Stomatitis | 2/22 (9.1%) | 0/5 (0%) | ||
| Diarrhoea | 1/22 (4.5%) | 0/5 (0%) | ||
| Enteritis | 1/22 (4.5%) | 0/5 (0%) | ||
| Haemorrhoids | 1/22 (4.5%) | 0/5 (0%) | ||
| Vomiting | 1/22 (4.5%) | 0/5 (0%) | ||
| General disorders | ||||
| Pyrexia | 3/22 (13.6%) | 0/5 (0%) | ||
| Chest pain | 1/22 (4.5%) | 0/5 (0%) | ||
| Malaise | 1/22 (4.5%) | 0/5 (0%) | ||
| Vessel puncture site bruise | 1/22 (4.5%) | 0/5 (0%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 1/22 (4.5%) | 0/5 (0%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 9/22 (40.9%) | 2/5 (40%) | ||
| Gastroenteritis | 4/22 (18.2%) | 0/5 (0%) | ||
| Influenza | 3/22 (13.6%) | 1/5 (20%) | ||
| Otitis media | 3/22 (13.6%) | 0/5 (0%) | ||
| Sinusitis | 2/22 (9.1%) | 0/5 (0%) | ||
| Upper respiratory tract infection | 2/22 (9.1%) | 0/5 (0%) | ||
| Adenoiditis | 1/22 (4.5%) | 0/5 (0%) | ||
| Adenovirus infection | 1/22 (4.5%) | 0/5 (0%) | ||
| Bronchitis | 1/22 (4.5%) | 0/5 (0%) | ||
| Conjunctivitis | 1/22 (4.5%) | 0/5 (0%) | ||
| Coxsackie viral infection | 1/22 (4.5%) | 0/5 (0%) | ||
| Lice infestation | 1/22 (4.5%) | 0/5 (0%) | ||
| Hordeolum | 1/22 (4.5%) | 0/5 (0%) | ||
| Mumps | 1/22 (4.5%) | 0/5 (0%) | ||
| Parotitis | 1/22 (4.5%) | 0/5 (0%) | ||
| Pharyngitis | 0/22 (0%) | 1/5 (20%) | ||
| Rhinitis | 0/22 (0%) | 1/5 (20%) | ||
| Streptococcal infection | 1/22 (4.5%) | 0/5 (0%) | ||
| Tinea manuum | 1/22 (4.5%) | 0/5 (0%) | ||
| Urinary tract infection | 1/22 (4.5%) | 0/5 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 2/22 (9.1%) | 0/5 (0%) | ||
| Ligament sprain | 2/22 (9.1%) | 0/5 (0%) | ||
| Ear injury | 1/22 (4.5%) | 0/5 (0%) | ||
| Heat stroke | 1/22 (4.5%) | 0/5 (0%) | ||
| Human bite | 1/22 (4.5%) | 0/5 (0%) | ||
| Ligament injury | 1/22 (4.5%) | 0/5 (0%) | ||
| Investigations | ||||
| Blood creatinine increased | 2/22 (9.1%) | 0/5 (0%) | ||
| Protein urine present | 1/22 (4.5%) | 0/5 (0%) | ||
| White blood cell count increased | 1/22 (4.5%) | 0/5 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperkalaemia | 1/22 (4.5%) | 0/5 (0%) | ||
| Metabolic acidosis | 1/22 (4.5%) | 0/5 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/22 (4.5%) | 0/5 (0%) | ||
| Muscle spasms | 0/22 (0%) | 1/5 (20%) | ||
| Musculoskeletal pain | 1/22 (4.5%) | 0/5 (0%) | ||
| Myalgia | 1/22 (4.5%) | 0/5 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 3/22 (13.6%) | 0/5 (0%) | ||
| Headache | 3/22 (13.6%) | 0/5 (0%) | ||
| Dizziness postural | 0/22 (0%) | 1/5 (20%) | ||
| Syncope | 0/22 (0%) | 1/5 (20%) | ||
| Renal and urinary disorders | ||||
| Renal impairment | 1/22 (4.5%) | 1/5 (20%) | ||
| Dysuria | 1/22 (4.5%) | 0/5 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 2/22 (9.1%) | 1/5 (20%) | ||
| Asthma | 2/22 (9.1%) | 0/5 (0%) | ||
| Cough | 2/22 (9.1%) | 0/5 (0%) | ||
| Nasal congestion | 1/22 (4.5%) | 0/5 (0%) | ||
| Nasal obstruction | 1/22 (4.5%) | 0/5 (0%) | ||
| Oropharyngeal pain | 1/22 (4.5%) | 0/5 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 1/22 (4.5%) | 0/5 (0%) | ||
| Dermatitis atopic | 2/22 (9.1%) | 0/5 (0%) | ||
| Eczema | 1/22 (4.5%) | 0/5 (0%) | ||
| Eczema asteatotic | 1/22 (4.5%) | 0/5 (0%) | ||
| Leukoderma | 1/22 (4.5%) | 0/5 (0%) | ||
| Skin erosion | 0/22 (0%) | 1/5 (20%) | ||
| Solar dermatitis | 1/22 (4.5%) | 0/5 (0%) | ||
| Urticaria | 1/22 (4.5%) | 0/5 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 1/22 (4.5%) | 0/5 (0%) | ||
| Orthostatic hypotension | 1/22 (4.5%) | 0/5 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
- TAK-536/OCT-101
- U1111-1182-4241
- JapicCTI-163260