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Essential HypertensionPhase 3NCT02480764

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

A Phase 3 study testing Azilsartan medoxomil and Valsartan in people with Essential Hypertension, run by Takeda at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Hypertension
What is being tested?
Azilsartan medoxomil and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
612 participants
Where
30 sitesChina
Study dates
27 Aug 2015to 13 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 22Show fewer
  • 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.)

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Hebei Cangzhou Central Hospital

    Cangzhou, Hebei, 061001

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130031

  • The Third Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410013

  • Hunan Province People's Hospital

    Changsha, Hunan, 410002

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Zhuzhou Central Hospital

    Fuzhou, Hunan, 421003

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Affiliated Hospital of Hainan Medical University.

    Haikou, Hainan, 570102

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006

  • Cardiology/Zhong Da Hospital, Southeast University

    Nanjing, Jiangsu, 210009

  • Nanjing Medical University Affiliated 2nd Hospital

    Nanjing, Jiangsu, 210011

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi Zhuang, 530021

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110015

  • The 4th Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50011

  • Cardiology/The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300170

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457

  • First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710061

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221002

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

About this study

Official title: 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

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.

Being tested
Azilsartan medoxomil, Valsartan, Azilsartan medoxomil Placebo, Valsartan Placebo
Keywords
Drug therapy
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azilsartan medoxomilDrug

    Also called TAK-491, Edarbi

    Azilsartan medoxomil tablets

  • ValsartanDrug

    Also called Diovan®

    Valsartan 80 mg capsules

  • Azilsartan medoxomil PlaceboDrug

    Azilsartan medoxomil placebo-matching tablets

  • Valsartan PlaceboDrug

    Valsartan placebo-matching capsules

Study groups in NCT02480764
Study groupRoleWhat they receive
Azilsartan medoxomil 40 mgExperimentalRun-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.
Receives: Drug: Azilsartan medoxomil; Drug: Azilsartan medoxomil Placebo; Drug: Valsartan Placebo
Azilsartan medoxomil 80 mgExperimentalRun-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.
Receives: Drug: Azilsartan medoxomil; Drug: Azilsartan medoxomil Placebo; Drug: Valsartan Placebo
Valsartan 160 mgActive 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.
Receives: Drug: Valsartan; Drug: Azilsartan medoxomil Placebo; Drug: Valsartan Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 8

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study start27 Aug 2015
  3. Primary completion22 Sep 2017
  4. Study completion13 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480764
Sponsor's protocol ID
TAK-491_305
Other IDs
U1111-1159-5579
Status last verified
Feb 2019
First submitted
22 Jun 2015
Last updated
5 Mar 2019
Data monitoring committee
No
Individual data sharing
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.

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.

    PubMed 32769878

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azilsartan medoxomil and Valsartan in people with Essential Hypertension, run by Takeda at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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