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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1130-9186 | Other Identifier | WHO |
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The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat Korean adults with hypertension. This study will look at changes in blood pressure in people who take azilsartan medoxomil.
The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take two tablets at the same time each day throughout the study.
This multi-centre trial will be conducted in Korea. The overall time to participate in this study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan Medoxomil 40 mg | Experimental | Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. |
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| Azilsartan Medoxomil 80 mg | Experimental | Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. |
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| Placebo | Placebo Comparator | Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan medoxomil | Drug | Azilsartan medoxomil tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP) | The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP) | The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon | Gangwon-do | South Korea | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29445520 | Derived | Juhasz A, Wu J, Hisada M, Tsukada T, Jeong MH. Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension. Clin Hypertens. 2018 Feb 7;24:2. doi: 10.1186/s40885-018-0086-4. eCollection 2018. |
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Participants with a diagnosis of essential hypertension were randomized at a ratio of 2:2:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, 80 mg or placebo. One participant in the 80 mg group was randomized twice, counted once in the randomized set, and is excluded from the Full Analysis Set and Safety Analysis Set.
Participants took part in the study at 29 investigative sites in Korea from 12 July 2014 to 03 February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks. |
| FG001 | Azilsartan Medoxomil 40 mg | Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Azilsartan medoxomil placebo | Drug | Azilsartan medoxomil placebo-matching tablets |
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| Baseline and Week 6 |
| Percentage of Participants Who Achieved a Clinic DBP Response at Week 6 | Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements. | Baseline and Week 6 |
| Percentage of Participants Who Achieved a Clinic SBP Response at Week 6 | SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements. | Baseline and Week 6 |
| Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6 | Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements. | Baseline and Week 6 |
| Wŏnju |
| Gangwon-do |
| South Korea |
| Anyang-si | Gyeonggi-do | South Korea |
| Goyang-si | Gyeonggi-do | South Korea |
| Seongnam-si | Gyeonggi-do | South Korea |
| Suwon | Gyeonggi-do | South Korea |
| Daegu | Gyeongsangbuk-do | South Korea |
| Yangsan | Gyeongsangnam-do | South Korea |
| Jeonju | Jeollabuk-do | South Korea |
| Gwangju | Jeollanam-do | South Korea |
| Busan | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| FG002 | Azilsartan Medoxomil 80 mg | Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. |
| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAS) included all participants who received at least 1 dose of double-blind study drug and were randomized only once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks. |
| BG001 | Azilsartan Medoxomil 40 mg | Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. |
| BG002 | Azilsartan Medoxomil 80 mg | Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Smoking Classification | Number | participants |
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| Female Reproductive Status | Female participants only (n=14, 37, 37) | Number | participants |
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| Estimated Glomerular Filtration Rate(eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Diabetes Status | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP) | The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis. | Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 6 |
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| Secondary | Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP) | The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis. | Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 6 |
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| Secondary | Percentage of Participants Who Achieved a Clinic DBP Response at Week 6 | Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements. | Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline and Week 6 |
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| Secondary | Percentage of Participants Who Achieved a Clinic SBP Response at Week 6 | SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements. | Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline and Week 6 |
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| Secondary | Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6 | Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements. | Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline and Week 6 |
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Treatment-emergent adverse events: from the first dose of double-blind study drug to 14 days after the last dose (up to 66 days). Serious adverse events: from the first dose of double blind study drug to 30 days after the last dose (up to 82 days).
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. Data is presented for the Safety Analysis Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks. | 0 | 65 | 7 | 65 | ||
| EG001 | Azilsartan Medoxomil 40 mg | Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks. | 0 | 132 | 8 | 132 | ||
| EG002 | Azilsartan Medoxomil 80 mg | Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. | 2 | 130 | 14 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
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| Male |
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| Current smoker |
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| Ex-smoker |
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| Surgically Sterile |
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| Of Childbearing Potential |
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| No |
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| ANCOVA | Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate. | <0.001 | Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis "all treatment groups equal" was first rejected at 0.05. | LS Mean Difference | -14.955 | Standard Error of the Mean | 2.4470 | 2-Sided | 95 | -19.770 | -10.141 | No | Superiority or Other |
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks. |
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