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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1159-5579 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.
The drug being tested in this study is called TAK-491 (azilsartan medoxomil). Azilsartan medoxomil is being tested to treat Chinese people who have essential hypertension. This study will look at change in blood pressure after 8 weeks of treatment in people who take azilsartan medoxomil compared to people who take valsartan.
The study enrolled 612 patients. Prior to the start of study treatment, participants who have not received antihypertensive treatment within 28 days participated in a 2-week -run in period. Upon completion of the run-in period, participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants were asked to take study medication at the same time each day throughout the study.
This multi-centre trial was conducted in China. The overall time to participate in this study is up to 14 weeks. Participants made 9 visits to the clinic and contacted by telephone 14 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 | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
|
| Azilsartan medoxomil 80 mg | Experimental | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
|
| Valsartan 160 mg | Active Comparator | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan medoxomil | Drug | Azilsartan medoxomil tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) | The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. |
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Inclusion Criteria:
Exclusion Criteria:
Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg at Day 1 (after placebo run in).
Is non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
Has secondary hypertension of any etiology (eg, renovascular disease documented as the cause of hypertension, pheochromocytoma, Cushing's syndrome).
Has a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).
Has severe renal dysfunction or disease (based on estimated glomerular filtration rate [GFR] <30 mL/min/1.73 m^2) at Screening.
Has known or suspected unilateral or bilateral renal artery stenosis.
Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those participants with basal cell or Stage 1 squamous cell carcinoma of the skin).
Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8.5%) at Screening.
Has hyperkalemia (defined as serum potassium above the normal reference range of the central laboratory) at Screening.
Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level of greater than 2.5 times the upper limit of normal (ULN), active liver disease, or jaundice at Screening.
Has any other known serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), any of its excipients or other angiotension II (AII) receptor blockers (ARBs).
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to the first dose of study medication.
Note: This criterion does not apply to participants who participated in observational studies that lacked an intervention or invasive procedure.
Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within the past 2 years.
Is taking or expected to take an excluded medication.
Works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]). (Only for participants with ambulatory blood pressure monitoring [ABPM].)
Has an upper arm circumference <24 cm or >42 cm. (Only for participants with ABPM.)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao Yang Hospital | Beijing | Beijing Municipality | 100020 | China | ||
| Beijing Anzhen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32769878 | Derived | Wu J, Du X, Lv Q, Li Z, Zheng Z, Xia Y, Tang C, Yao Z, Zhang J, Long M, Hisada M, Wu J, Zhou W, Ma C. A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension. Medicine (Baltimore). 2020 Aug 7;99(32):e21465. doi: 10.1097/MD.0000000000021465. |
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Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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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Participants with a diagnosis of hypertension were randomized at a ratio of 1:1:1 into 1 of 3 treatment groups, once a day azilsartan medoxomil 40 mg, azilsartan medoxomil 80 mg or valsartan 160 mg.
Participants took part in the study at 30 investigative sites in China from 27 August 2015 to 13 October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoxomil 40 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2016 | Sep 18, 2018 |
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| Valsartan | Drug | Valsartan 80 mg capsules |
|
|
| Azilsartan medoxomil Placebo | Drug | Azilsartan medoxomil placebo-matching tablets |
|
| Valsartan Placebo | Drug | Valsartan placebo-matching capsules |
|
| Baseline and Week 8 |
| Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Week 8 |
| Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | Clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Week 8 |
| Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Week 8 |
| Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Week 8 |
| Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Week 8 |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Tong Ren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi Zhuang | 530021 | China |
| Affiliated Hospital of Hainan Medical University. | Haikou | Hainan | 570102 | China |
| Hebei Cangzhou Central Hospital | Cangzhou | Hebei | 061001 | China |
| The 4th Hospital of Hebei Medical University | Shijiazhuang | Hebei | 50011 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hu'nan | 410013 | China |
| Hunan Province People's Hospital | Changsha | Hunan | 410002 | China |
| Zhuzhou Central Hospital | Fuzhou | Hunan | 421003 | China |
| Cardiology/Zhong Da Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China |
| Nanjing Medical University Affiliated 2nd Hospital | Nanjing | Jiangsu | 210011 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | 221002 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212001 | China |
| The First Affiliated Hospital of NanChang University | Nanchang | Jiangxi | 330006 | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130031 | China |
| People's Hospital of Liaoning Province | Shenyang | Liaoning | 110015 | China |
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
| Cardiology/The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| First Affiliated Hospital of Xian Jiaotong University | Xi’an | Shanxi | 710061 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| Tianjin Third Central Hospital | Tianjin | Tianjin Municipality | 300170 | China |
| TEDA International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
| FG001 | Azilsartan Medoxomil 80 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| FG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who received at least 1 dose of double-blind study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoxomil 40 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| BG001 | Azilsartan Medoxomil 80 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. |
| BG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | BMI=(baseline weight in kg)/(height in cm)/100)^2 | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Smoking Classification | Count of Participants | Participants |
| ||||||||||||||||
| Female Reproductive Status | Count of Participants | Participants |
| ||||||||||||||||
| Estimated Glomerular Filtration Rate (eGFR) | Calculated using the Modification of Diet in Renal Disease (MDRD) formula. | Mean | Standard Deviation | mL/min/1.73m^2 |
| ||||||||||||||
| Baseline glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | Percentage of glycosylated haemoglobin |
|
| 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 in Trough Sitting Clinic Systolic Blood Pressure (SBP) | The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | Full Analysis Set (FAS) included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using last observation carried forward (LOCF). Number analyzed at a visit is the number of participants with data available for analysis at the given time-point. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
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| Secondary | Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) | The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. Number analyzed at a visit is the number of participants with data available for analysis at the given time-point. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
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| Secondary | Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 | Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. | Posted | Number | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 | Clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. | Posted | Number | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 | Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. | Posted | Number | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. | Posted | Number | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 | Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. | FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. | Posted | Number | percentage of participants | Week 8 |
|
From first dose of study drug through 14 days after the last dose of study drug (Up to Week 12)
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.
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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 | Azilsartan Medoxomil 40 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 40 mg tablets, orally, once daily, azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. | 1 | 199 | 2 | 199 | 34 | 199 |
| EG001 | Azilsartan Medoxomil 80 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: azilsartan medoxomil 80 mg tablets, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for up to 8 weeks. | 0 | 209 | 7 | 209 | 37 | 209 |
| EG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. | 0 | 204 | 6 | 204 | 35 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Urate nephropathy | Renal and urinary disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Ureteral cyst | Renal and urinary disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v 20_MIXED | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v 20_MIXED | Systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA v 20_MIXED | Systematic Assessment |
|
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2017 | Sep 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
| C521273 | azilsartan |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
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| Male |
|
| Participant is a current smoker |
|
| Participant is an ex-smoker |
|
| Surgically Sterile |
|
| Female of Childbearing Potential |
|
| N/A (Participant is Male) |
|
| Change at Week 8 |
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| ANCOVA | 0.010 | Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate. | Least Square Mean Difference | -3.685 | Standard Error of the Mean | 1.4344 | 2-Sided | 95 | -6.502 | -0.868 | Non-Inferiority | A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level. |
| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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| OG002 | Valsartan 160 mg | Run-in Period: azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and valsartan two 80 mg placebo-matching capsules, orally, once daily, for 2 weeks prior to the start of the treatment period. Treatment Period: valsartan two 80 mg capsules, orally, once daily, azilsartan medoxomil 40 mg placebo-matching tablets, orally, once daily, and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily, for up to 8 weeks. |
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