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Azilsartan Medoxomil (TAK-491) Compared to Placebo in Korean Adults With Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203916
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil versus placebo in Korean adults with essential hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Azilsartan medoxomil Drug: Azilsartan medoxomil placebo Phase 3

Detailed Description:

The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat Korean adults with hypertension. This study will look at changes in blood pressure in people who take azilsartan medoxomil.

The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will 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
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take two tablets at the same time each day throughout the study.

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is 12 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-491 in Korean Subjects With Essential Hypertension
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azilsartan Medoxomil 40 mg
Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
Drug: Azilsartan medoxomil
Azilsartan medoxomil tablets
Other Name: TAK-491

Experimental: Azilsartan Medoxomil 80 mg
Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
Drug: Azilsartan medoxomil
Azilsartan medoxomil tablets
Other Name: TAK-491

Placebo Comparator: Placebo
Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
Drug: Azilsartan medoxomil placebo
Azilsartan medoxomil placebo-matching tablets




Primary Outcome Measures :
  1. Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Week 6 ]
    The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.


Secondary Outcome Measures :
  1. Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Week 6 ]
    The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.

  2. Percentage of Participants Who Achieved a Clinic DBP Response at Week 6 [ Time Frame: Baseline and Week 6 ]
    Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.

  3. Percentage of Participants Who Achieved a Clinic SBP Response at Week 6 [ Time Frame: Baseline and Week 6 ]
    SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.

  4. Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6 [ Time Frame: Baseline and Week 6 ]
    Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. 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.
  3. 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 patient 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.
  4. Is male or female aged ≥19 years.
  5. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent through 30 days after last study drug dose.
  6. Is willing to discontinue current antihypertensive medications on Day -21. If on amlodipine or chlorthalidone prior to Screening, the participant is willing to discontinue this medication on Day -28.

Exclusion Criteria:

  1. Has received any investigational compound within 30 days prior to the first dose of study medication.
  2. Has received TAK-491 in a previous clinical study or as a therapeutic agent.
  3. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  4. Has sitting trough clinic diastolic blood pressure (DBP) greater than 114 mm Hg at Day 1 (after placebo run-in).
  5. Has a history of hypersensitivity to TAK-491 (azilsartan medoxomil), any of its excipients, or other angiotensin-converting enzyme (ARBs).
  6. 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.
  7. Has clinically significant cardiac conduction defects (e.g., 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation, or flutter).
  8. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).
  9. Has secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing syndrome).
  10. Is noncompliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
  11. Has severe renal dysfunction or disease (confirmed by calculated creatinine clearance <30 mL/min/1.73m^2) at Screening.
  12. Has known or suspected unilateral or bilateral renal artery stenosis.
  13. Has a history of drug or alcohol abuse within the past 2 years.
  14. 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 patients with basal cell or stage I squamous cell carcinoma of the skin.)
  15. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c]>8.0%) at Screening.
  16. Has an alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
  17. Has hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening.
  18. Has any other 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.
  19. Is required to take excluded medications.
  20. If female, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203916


Locations
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Korea, Republic of
Chuncheon-Si, Gangwon-do, Korea, Republic of
Wonju-Si, Gangwon-do, Korea, Republic of
Anyang-si, Gyeonggi-do, Korea, Republic of
Goyang-si, Gyeonggi-do, Korea, Republic of
Seongnam-si, Gyeonggi-do, Korea, Republic of
Suwon-si, Gyeonggi-do, Korea, Republic of
Daegu, Gyeongsangbuk-do, Korea, Republic of
Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Jeonju-si, Jeollabuk-do, Korea, Republic of
Gwangju, Jeollanam-do, Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02203916    
Other Study ID Numbers: TAK-491_307
U1111-1130-9186 ( Other Identifier: WHO )
First Posted: July 30, 2014    Key Record Dates
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016
Last Verified: October 2016
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action