Phase
Condition
Williams Syndrome
High Blood Pressure (Hypertension - Pediatric)
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is treated with antihypertensive therapy and has a post-washout mean sitting clinicsystolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the participant has notreceived antihypertensive treatment within 28 days prior to Screening and has a meansitting clinic SBP ≥150 and ≤180 mm Hg at the Screening Visit and on Day 1.
Is a man or woman aged 18 years or older.
In the opinion of the investigator, the participant is capable of understanding andcomplying with protocol requirements.
The participant or, when applicable, the participant's legally acceptablerepresentative signs and dates a written, informed consent form and any requiredprivacy authorization prior to the initiation of any study procedures.
A female participant of childbearing potential who is sexually active with anonsterilized male partner agrees to use routinely adequate contraception from signingof informed consent through 30 days after last study drug dose.
Has clinical laboratory test results (clinical chemistry, hematology, and completeurinalysis) within the reference range for the testing laboratory or the investigatordoes not consider the results to be clinically significant.
Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if the participant is on amlodipine or chlorthalidone.
Exclusion
Exclusion Criteria:
Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg atDay 1 (after placebo run in).
Is non-compliant (less than 70% or greater than 130%) with study medication duringplacebo run-in period.
Has secondary hypertension of any etiology (eg, renovascular disease documented as thecause of hypertension, pheochromocytoma, Cushing's syndrome).
Has a history of myocardial infarction, heart failure, unstable angina, coronaryartery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,cerebrovascular accident, or transient ischemic attack.
Has clinically significant cardiac conduction defects (eg, third-degreeatrioventricular block, sick sinus syndrome).
Has hemodynamically significant left ventricular outflow obstruction due to aorticvalvular 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 tothe first dose of study drug. (This criterion does not apply to those participantswith 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 thecentral laboratory) at Screening.
Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ofgreater than 2.5 times the upper limit of normal (ULN), active liver disease, orjaundice at Screening.
Has any other known serious disease or condition at Screening (or Randomization) thatwould compromise participant safety, might affect life expectancy, or make itdifficult to successfully manage and follow the participant according to the protocol.
Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), anyof its excipients or other angiotension II (AII) receptor blockers (ARBs).
If female, the participant is pregnant or lactating or intending to become pregnantbefore, during, or within 30 days after participating in this study; or intending todonate ova during such time period.
Is currently participating in another investigational study or is receiving or hasreceived any investigational compound within 30 days prior to the first dose of studymedication. Note: This criterion does not apply to participants who participated in observationalstudies that lacked an intervention or invasive procedure.
Is an immediate family member, study site employee, or is in a dependant relationshipwith 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 alcoholabuse 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 forparticipants with ambulatory blood pressure monitoring [ABPM].)
Has an upper arm circumference <24 cm or >42 cm. (Only for participants with ABPM.)
Study Design
Study Description
Connect with a study center
Beijing Anzhen Hospital
Beijing, Beijing 100029
ChinaSite Not Available
Beijing Chao Yang Hospital
Beijing, Beijing 100020
ChinaSite Not Available
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing 100730
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Fujian Provincial Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005
ChinaSite Not Available
Guangdong General Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi 530021
ChinaSite Not Available
Affiliated Hospital of Hainan Medical University.
Haikou, Hainan 570102
ChinaSite Not Available
Hebei Cangzhou Central Hospital
Cangzhou, Hebei 061001
ChinaSite Not Available
The 4th Hospital of Hebei Medical University
Shijiazhuang, Hebei 50011
ChinaSite Not Available
empty
Wuhan, Hubei
ChinaSite Not Available
Hunan Province People's Hospital
Changsha, Hunan 410002
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha, Hunan 410013
ChinaSite Not Available
Zhuzhou Central Hospital
Fuzhou, Hunan 421003
ChinaSite Not Available
Cardiology/Zhong Da Hospital, Southeast University
Nanjing, Jiangsu 210009
ChinaSite Not Available
Nanjing Medical University Affiliated 2nd Hospital
Nanjing, Jiangsu 210011
ChinaSite Not Available
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu 221002
ChinaSite Not Available
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
China-Japan Union Hospital of Jilin University
Changchun, Jilin 130031
ChinaSite Not Available
People's Hospital of Liaoning Province
Shenyang, Liaoning 110015
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai, Shanghai 200003
ChinaSite Not Available
Shanghai East Hospital
Shanghai, Shanghai 200120
ChinaSite Not Available
Cardiology/The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
ChinaSite Not Available
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shanxi 710061
ChinaSite Not Available
TEDA International Cardiovascular Hospital
Tianjin, Tianjin 300457
ChinaSite Not Available
Tianjin People's Hospital
Tianjin, Tianjin 300121
ChinaSite Not Available
Tianjin Third Central Hospital
Tianjin, Tianjin 300170
ChinaSite Not Available
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