Azilsartan Medoxomil (TAK-491) Compared to Valsartan in Chinese Participants With Hypertension

Last updated: February 15, 2019
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

High Blood Pressure (Hypertension - Pediatric)

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02480764
TAK-491_305
U1111-1159-5579
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Is a man or woman aged 18 years or older.

  3. In the opinion of the investigator, the participant is capable of understanding andcomplying with protocol requirements.

  4. 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.

  5. 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.

  6. 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.

  7. 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:

  1. Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg atDay 1 (after placebo run in).

  2. Is non-compliant (less than 70% or greater than 130%) with study medication duringplacebo run-in period.

  3. Has secondary hypertension of any etiology (eg, renovascular disease documented as thecause of hypertension, pheochromocytoma, Cushing's syndrome).

  4. Has a history of myocardial infarction, heart failure, unstable angina, coronaryartery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy,cerebrovascular accident, or transient ischemic attack.

  5. Has clinically significant cardiac conduction defects (eg, third-degreeatrioventricular block, sick sinus syndrome).

  6. Has hemodynamically significant left ventricular outflow obstruction due to aorticvalvular disease and hypertrophic obstructive cardiomyopathy (HOCM).

  7. Has severe renal dysfunction or disease (based on estimated glomerular filtration rate [GFR] <30 mL/min/1.73 m^2) at Screening.

  8. Has known or suspected unilateral or bilateral renal artery stenosis.

  9. 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).

  10. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8.5%) at Screening.

  11. Has hyperkalemia (defined as serum potassium above the normal reference range of thecentral laboratory) at Screening.

  12. 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.

  13. 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.

  14. Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), anyof its excipients or other angiotension II (AII) receptor blockers (ARBs).

  15. 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.

  16. 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.

  17. 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.

  18. Has a history of drug abuse (defined as any illicit drug use) or a history of alcoholabuse within the past 2 years.

  19. Is taking or expected to take an excluded medication.

  20. Works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]). (Only forparticipants with ambulatory blood pressure monitoring [ABPM].)

  21. Has an upper arm circumference <24 cm or >42 cm. (Only for participants with ABPM.)

Study Design

Total Participants: 612
Study Start date:
August 27, 2015
Estimated Completion Date:
October 13, 2017

Study Description

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):

  • azilsartan medoxomil 40 mg

  • azilsartan medoxomil 80 mg

  • Valsartan 160 mg

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.

Connect with a study center

  • Beijing Anzhen Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

  • Beijing Chao Yang Hospital

    Beijing, Beijing 100020
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, Beijing 100730
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Provincial Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Affiliated Hospital of Hainan Medical University.

    Haikou, Hainan 570102
    China

    Site Not Available

  • Hebei Cangzhou Central Hospital

    Cangzhou, Hebei 061001
    China

    Site Not Available

  • The 4th Hospital of Hebei Medical University

    Shijiazhuang, Hebei 50011
    China

    Site Not Available

  • empty

    Wuhan, Hubei
    China

    Site Not Available

  • Hunan Province People's Hospital

    Changsha, Hunan 410002
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Zhuzhou Central Hospital

    Fuzhou, Hunan 421003
    China

    Site Not Available

  • Cardiology/Zhong Da Hospital, Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Nanjing Medical University Affiliated 2nd Hospital

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu 221002
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin 130031
    China

    Site Not Available

  • People's Hospital of Liaoning Province

    Shenyang, Liaoning 110015
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 200003
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Cardiology/The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin 300457
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • Tianjin Third Central Hospital

    Tianjin, Tianjin 300170
    China

    Site Not Available

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