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CompletedNCT02480764Updated Mar 5, 2019Results posted

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

A Phase 3 interventional study of Azilsartan medoxomil and Valsartan in Essential Hypertension, sponsored by Takeda. Completed at 30 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
612
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Drug therapy
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 612 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Is a man or woman aged 18 years or older.
  3. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  4. 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.
  5. 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.
  6. 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.
  7. Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if the participant is on amlodipine or chlorthalidone.

Exclusion criteria

Exclusion Criteria:

  1. Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg at Day 1 (after placebo run in).
  2. Is non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
  3. Has secondary hypertension of any etiology (eg, renovascular disease documented as the cause of hypertension, pheochromocytoma, Cushing's syndrome).
  4. 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.
  5. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
  6. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular 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 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).
  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 the central laboratory) at Screening.
  12. 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.
  13. 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.
  14. Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), any of its excipients or other angiotension II (AII) receptor blockers (ARBs).
  15. 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.

  16. 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.

  17. 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.
  18. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse 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 for participants with ambulatory blood pressure monitoring [ABPM].)
  21. Has an upper arm circumference \<24 cm or >42 cm. (Only for participants with ABPM.)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
612 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Azilsartan medoxomil · Drug: Azilsartan medoxomil Placebo · Drug: Valsartan Placebo

  • Experimental
    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.

    Drug: Azilsartan medoxomil · Drug: Azilsartan medoxomil Placebo · Drug: Valsartan Placebo

  • Active comparator
    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.

    Drug: Valsartan · Drug: Azilsartan medoxomil Placebo · Drug: Valsartan Placebo

Interventions

  • DrugAzilsartan medoxomil

    Azilsartan medoxomil tablets

    Also known as: TAK-491, Edarbi

  • DrugValsartan

    Valsartan 80 mg capsules

    Also known as: Diovan®

  • DrugAzilsartan medoxomil Placebo

    Azilsartan medoxomil placebo-matching tablets

  • DrugValsartan Placebo

    Valsartan placebo-matching capsules

06

What researchers measure

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.

    Time frame: Baseline and Week 8

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 8

  2. 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.

    Time frame: Week 8

  3. 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.

    Time frame: Week 8

  4. 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.

    Time frame: Week 8

  5. 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.

    Time frame: Week 8

  6. 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.

    Time frame: Week 8

07

Results

Posted Feb 11, 2019

Participant flow

Participants took part in the study at 30 investigative sites in China from 27 August 2015 to 13 October 2017.

Participant flow — Overall Study
MilestoneAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Started199209204
Completed189189183
Not completed102021
Withdrew: Pretreatment event/adverse event363
Withdrew: Major protocol deviation143
Withdrew: Lost to follow-up012
Withdrew: Voluntary withdrawal6510
Withdrew: Lack of efficacy033
Withdrew: Reason not specified010

Outcome measures

PrimaryChange 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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · mm Hg
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP)
mm HgAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Baseline SBP157.873 ± 0.5123158.236 ± 0.5010158.594 ± 0.5123
Change at Week 8-22.483 ± 1.0258-24.236 ± 1.0027-20.551 ± 1.0258
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · ANCOVA · p = 0.184 (Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.) · Least square mean difference: -1.932 · 95% CI -4.782 to 0.918
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · ANCOVA · p = 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 · 95% CI -6.502 to -0.868
SecondaryChange 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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · mm Hg
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP)
mm HgAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Baseline DBP91.790 ± 0.730691.510 ± 0.714592.298 ± 0.7306
Change at Week 8-10.101 ± 0.6684-11.463 ± 0.6538-8.641 ± 0.6686
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · ANCOVA · p = 0.123 (Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.) · Least square mean difference: -1.459 · 95% CI -3.316 to 0.397
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · ANCOVA · p = 0.003 (Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.) · Least square mean difference: -2.822 · 95% CI -4.659 to -0.985
SecondaryPercentage 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.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved a Clinic SBP Response at Week 8
percentage of participantsAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Percentage of Participants Who Achieved a Clinic SBP Response at Week 867.068.969.0
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.548 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 0.877 · 95% CI 0.571 to 1.347
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.921 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 0.979 · 95% CI 0.638 to 1.501
SecondaryPercentage 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.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved a Clinic DBP Response at Week 8
percentage of participantsAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Percentage of Participants Who Achieved a Clinic DBP Response at Week 881.281.679.7
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.904 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 1.033 · 95% CI 0.607 to 1.759
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.790 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 1.074 · 95% CI 0.633 to 1.823
SecondaryPercentage 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.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8
percentage of participantsAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 862.967.064.5
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.624 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 0.901 · 95% CI 0.594 to 1.367
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.647 (P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.103 · 95% CI 0.726 to 1.674
SecondaryPercentage 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.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8
percentage of participantsAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Clinic SBP <140 mm Hg60.962.662.9
Clinic DBP <90 mm Hg77.276.774.6
Clinic SBP <140 mm Hg and DBP <90 mm Hg58.460.255.8
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.404 (Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 0.831 · 95% CI 0.537 to 1.284
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.768 (Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 0.937 · 95% CI 0.606 to 1.447
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.852 (Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 1.051 · 95% CI 0.620 to 1.784
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.868 (Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 1.045 · 95% CI 0.620 to 1.763
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.847 (Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.042 · 95% CI 0.684 to 1.590
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.460 (Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.172 · 95% CI 0.769 to 1.785
SecondaryPercentage 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.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8
percentage of participantsAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Clinic SBP <130 mm Hg37.642.728.4
Clinic DBP <80 mm Hg45.251.937.1
Clinic SBP <130 mm Hg and DBP <80 mm Hg28.933.021.8
Statistical analysis
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.077 (Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.487 · 95% CI 0.958 to 2.307
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.003 (Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.914 · 95% CI 1.241 to 2.951
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.137 (Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 1.427 · 95% CI 0.893 to 2.280
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.003 (Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.) · Odds ratio (or): 2.017 · 95% CI 1.263 to 3.220
  • Azilsartan Medoxomil 40 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.140 (Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.424 · 95% CI 0.891 to 2.276
  • Azilsartan Medoxomil 80 mg vs Valsartan 160 mg · Regression, Logistic · p = 0.015 (Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.) · Odds ratio (or): 1.769 · 95% CI 1.118 to 2.797

Adverse events

Collected over From first dose of study drug through 14 days after the last dose of study drug (Up to Week 12). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Azilsartan Medoxomil 40 mg1/199 (0.5%)2/199 (1%)34/199 (17.1%)
Azilsartan Medoxomil 80 mg0/209 (0%)7/209 (3.3%)37/209 (17.7%)
Valsartan 160 mg0/204 (0%)6/204 (2.9%)35/204 (17.2%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
Subarachnoid haemorrhageInjury, poisoning and procedural complications1/1990/2090/204
HypertensionVascular disorders1/1991/2091/204
PneumoniaInfections and infestations0/1990/2091/204
Musculoskeletal painMusculoskeletal and connective tissue disorders0/1990/2091/204
Lacunar infarctionNervous system disorders0/1991/2091/204
Cerebrovascular insufficiencyNervous system disorders0/1990/2091/204
Urate nephropathyRenal and urinary disorders0/1990/2091/204
Peptic ulcer haemorrhageGastrointestinal disorders0/1991/2090/204
Meniscus injuryInjury, poisoning and procedural complications0/1991/2090/204
Ovarian neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1991/2090/204
Most frequent other events
Most frequent other events
EventAzilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mg
HyperlipidaemiaMetabolism and nutrition disorders14/19914/20916/204
Upper respiratory tract infectionInfections and infestations10/19913/20914/204
AlbuminuriaRenal and urinary disorders11/19910/2096/204
HyperuricaemiaMetabolism and nutrition disorders8/19911/2098/204

Baseline characteristics

Safety Analysis Set included all participants who received at least 1 dose of double-blind study drug.

Age, Continuous
Age, Continuous(years)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Mean57.4 ± 9.5257.0 ± 9.8856.8 ± 9.4857.1 ± 9.62
Sex: Female, Male
Sex: Female, Male(Participants)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Female929474260
Male107115130352
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Asian199209204612
Region of Enrollment
Region of Enrollment(Participants)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
China199209204612
Height
Height(cm)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Mean164.3 ± 8.92164.2 ± 8.81165.3 ± 7.73164.6 ± 8.50
Weight
Weight(kg)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Mean71.75 ± 14.04671.60 ± 11.90372.79 ± 12.90372.05 ± 12.952
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Mean26.43 ± 3.78426.47 ± 3.43626.52 ± 3.44426.48 ± 3.550
Smoking Classification
Smoking Classification(Participants)Azilsartan Medoxomil 40 mgAzilsartan Medoxomil 80 mgValsartan 160 mgTotal
Participant has never smoked151147136434
Participant is a current smoker395155145
Participant is an ex-smoker9111333

3 further baseline measures are reported on the registry.

08

Study locations

30 sites
  • Beijing Chao Yang Hospital
    Beijing, Beijing 100020, China
  • Beijing Anzhen Hospital
    Beijing, Beijing 100029, China
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
  • Beijing Tong Ren Hospital, Capital Medical University
    Beijing, Beijing 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 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
  • Hunan Province People's Hospital
    Changsha, Hunan 410002, China
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410013, 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 200003, China
  • Shanghai East Hospital
    Shanghai, Shanghai 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 300121, China
  • Tianjin Third Central Hospital
    Tianjin, Tianjin 300170, China
  • TEDA International Cardiovascular Hospital
    Tianjin, Tianjin 300457, China
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References and documents

Publications

  • 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. Erratum In: Medicine (Baltimore). 2020 Sep 4;99(36):e22168. doi: 10.1097/MD.0000000000022168. PubMed 32769878 ↗

Study documents

  • Study protocol · May 9, 2016
  • Statistical analysis plan · Nov 29, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02480764
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
Aug 27, 2015
Primary completion
Sep 22, 2017
Completion
Oct 13, 2017
Results posted
Feb 11, 2019
Last update
Mar 5, 2019

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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