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

NCT02203916 | Completed Phase 3 Results

• 2 other identifiers: TAK-491_307U1111-1130-9186
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Hypertension

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)

  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.

  Baseline and Week 6

Secondary Outcomes (4)

• Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)

  Baseline and Week 6

• Percentage of Participants Who Achieved a Clinic DBP Response at Week 6

  Baseline and Week 6

• Percentage of Participants Who Achieved a Clinic SBP Response at Week 6

  Baseline and Week 6

• Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6

  Baseline and Week 6

Study Arms (3)

Azilsartan Medoxomil 40 mg

EXPERIMENTAL

Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.

Drug: Azilsartan medoxomil

Azilsartan Medoxomil 80 mg

EXPERIMENTAL

Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.

Drug: Azilsartan medoxomil

Placebo

PLACEBO COMPARATOR

Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.

Drug: Azilsartan medoxomil placebo

Interventions

Azilsartan medoxomil DRUG

Azilsartan medoxomil tablets

Also known as: TAK-491

Azilsartan Medoxomil 40 mg; Azilsartan Medoxomil 80 mg

Azilsartan medoxomil placebo DRUG

Azilsartan medoxomil placebo-matching tablets

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Is male or female aged ≥19 years.
• 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.
• 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.

You may not qualify if:

• Has received any investigational compound within 30 days prior to the first dose of study medication.
• Has received TAK-491 in a previous clinical study or as a therapeutic agent.
• 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.
• Has sitting trough clinic diastolic blood pressure (DBP) greater than 114 mm Hg at Day 1 (after placebo run-in).
• Has a history of hypersensitivity to TAK-491 (azilsartan medoxomil), any of its excipients, or other angiotensin-converting enzyme (ARBs).
• 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 (e.g., 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation, or flutter).
• Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).
• Has secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing syndrome).
• Is noncompliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
• Has severe renal dysfunction or disease (confirmed by calculated creatinine clearance \<30 mL/min/1.73m\^2) at Screening.
• Has known or suspected unilateral or bilateral renal artery stenosis.
• Has a history of drug or alcohol abuse within the past 2 years.
• 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.)
• Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c \[HbA1c\]\>8.0%) at Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

Unknown Facility

Chuncheon, Gangwon-do, South Korea

Location

Unknown Facility

Wŏnju, Gangwon-do, South Korea

Location

Unknown Facility

Anyang-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Seongnam-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Suwon, Gyeonggi-do, South Korea

Location

Unknown Facility

Daegu, Gyeongsangbuk-do, South Korea

Location

Unknown Facility

Yangsan, Gyeongsangnam-do, South Korea

Location

Unknown Facility

Jeonju, Jeollabuk-do, South Korea

Location

Unknown Facility

Gwangju, Jeollanam-do, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• Juhasz A, Wu J, Hisada M, Tsukada T, Jeong MH. Efficacy and safety of azilsartan medoxomil, an angiotensin receptor blocker, in Korean patients with essential hypertension. Clin Hypertens. 2018 Feb 7;24:2. doi: 10.1186/s40885-018-0086-4. eCollection 2018.

  PMID: 29445520 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

azilsartan medoxomil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

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: July 28, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 19, 2016
• Results First Posted: December 19, 2016

Record last verified: 2016-10

Locations

KR (15)