Azilsartan Medoxomil (TAK-491) Compared to Valsartan in Chinese Participants With Hypertension
A Phase 3, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Chinese Subjects With Essential Hypertension
2 other identifiers
interventional
612
1 country
30
Brief Summary
The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
August 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2017
CompletedResults Posted
Study results publicly available
February 11, 2019
CompletedMarch 5, 2019
February 1, 2019
2.1 years
June 22, 2015
September 18, 2018
February 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP)
Baseline and Week 8
Percentage of Participants Who Achieved a Clinic SBP Response at Week 8
Week 8
Percentage of Participants Who Achieved a Clinic DBP Response at Week 8
Week 8
Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8
Week 8
Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8
Week 8
- +1 more secondary outcomes
Study Arms (3)
Azilsartan medoxomil 40 mg
EXPERIMENTALRun-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
EXPERIMENTALRun-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 COMPARATORRun-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.
Interventions
Azilsartan medoxomil tablets
Azilsartan medoxomil placebo-matching tablets
Valsartan placebo-matching capsules
Eligibility Criteria
You may qualify if:
- Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure (SBP) ≥150 and ≤180 mm Hg on Day 1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting 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 and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- 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 30 days after last study drug dose.
- Has clinical laboratory test results (clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the investigator does 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.
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (30)
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Beijing Anzhen Hospital
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
Related Publications (1)
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.
PMID: 32769878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 24, 2015
Study Start
August 27, 2015
Primary Completion
September 22, 2017
Study Completion
October 13, 2017
Last Updated
March 5, 2019
Results First Posted
February 11, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
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.