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AzTrials

HypertensionPhase 3NCT00591578

Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension

A Phase 3 study testing Azilsartan Medoxomil and Valsartan in people with Hypertension, run by Takeda at 88 sites in 4 countries.

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 compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Azilsartan Medoxomil and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
88 sitesin 4 countries
Study dates
Dec 2007to Mar 2010
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

  • Essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg inclusive at Day minus 1 and 24-hour mean systolic blood pressure between 130 and 170 mm Hg inclusive at Day 1).
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
  • Willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to Screening, the subject is willing to discontinue this medication at Screening Day minus 28.

Who cannot join

  • Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1.
  • The subject has a baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
  • Hypersensitive to angiotensin II receptor blockers.
  • Recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
  • Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
Show all 21Show fewer
  • Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
  • Secondary hypertension of any etiology.
  • Non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period.
  • Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL per min/1.73m2) at Screening.
  • Known or suspected unilateral or bilateral renal artery stenosis.
  • History of drug or alcohol abuse within the past 2 years.
  • Previous 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 subjects with basal cell or Stage 1 squamous cell carcinoma of the skin).
  • Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.
  • Hyperkalemia as defined by the central laboratory normal reference range at Screening.
  • Upper arm circumference less than 24 cm or greater than 42 cm.
  • Works night (3rd) shift (defined as 11PM to 7AM).
  • Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
  • Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
  • Any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
  • Randomized in a previous azilsartan medoxomil study.

Trial locations and contacts

88 sites in 4 countries.

88 sites in 4 countries

United States77 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington, Virginia

  • Study site

    Austin, Texas

  • Study site

    Avon, Indiana

  • Study site

    Baltimore, Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Bloomington, Indiana

  • Study site

    Boise, Idaho

  • Study site

    Bridgeville, Pennsylvania

  • Study site

    Brockton, Massachusetts

  • Study site

    Burbank, California

  • Study site

    Burke, Virginia

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    City of Saint Peters, Missouri

  • Study site

    Columbia, Maryland

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Delaware, Ohio

  • Study site

    Downingtown, Pennsylvania

  • Study site

    Eugene, Oregon

  • Study site

    Florissant, Missouri

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Glendale, Arizona

  • Study site

    Gurnee, Illinois

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Inverness, Florida

  • Study site

    Jacksonville, Florida

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lakewood, Washington

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Menomonee Falls, Wisconsin

  • Study site

    Mogadore, Ohio

  • Study site

    Morton, Illinois

  • Study site

    Newark, Delaware

  • Study site

    Norfolk, Virginia

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Paramount, California

  • Study site

    Park Ridge, Illinois

  • Study site

    Pearland, Texas

  • Study site

    Phoenix, Arizona

  • Study site

    Port Richard, Washington

  • Study site

    Portland, Oregon

  • Study site

    Ridgefield, Connecticut

  • Study site

    Riverton, Utah

  • Study site

    Rosenberg, Texas

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Shelby, North Carolina

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spring Valley, California

  • Study site

    Tuscon, Arizona

  • Study site

    Tustin, California

  • Study site

    Vista, California

  • Study site

    Washington, Missouri

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wentzville, Missouri

  • Study site

    West Jordan, Utah

  • Study site

    West Yarmouth, Massachusetts

  • Study site

    Westlake Village, California

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Zanesville, Ohio

Other trials in United States

Mexico7 sites

  • Study site

    Cabo San Lucas

  • Study site

    Colonia Escandón

  • Study site

    Culiacán

  • Study site

    Mexico City

  • Study site

    Monterrey Nuevo Leon

  • Study site

    Morelia

  • Study site

    Querétaro

Other trials in Mexico

Chile2 sites

  • Study site

    Santiago

  • Study site

    Temuco

Other trials in Chile

Peru2 sites

  • Study site

    Chiclayo

  • Study site

    Lima

Other trials in Peru

About this study

Official title: A Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of TAK-491 With Valsartan in Subjects With Essential Hypertension

The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension.

Read the detailed description

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization (WHO), hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.

This study is being conducted to determine whether administration of azilsartan medoxomil in subjects with essential hypertension is more efficacious in reducing systolic blood pressure than valsartan.

Study participation is anticipated to be approximately 7 months. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Following completion of the 6-month double-blind treatment period, all available subjects will be offered the option to continue in a 28-week extension study with open-label azilsartan medoxomil 40 mg.

For the extension study, participants will take azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 28 weeks. Hydrochlorothiazide 12.5 mg or 25 mg or any other antihypertensive (except angiotensin II receptor blockers) may be added in a step-wise fashion to maintain blood pressure within target <140/90 mmHg for non-diabetic subjects and <130/80 mmHg for diabetic subjects

Conditions
Hypertension
Being tested
Azilsartan Medoxomil, Valsartan
Keywords
Blood pressure, blood pressure monitoring, ambulatory
Medical subject headings
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 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.

  • Azilsartan MedoxomilDrug

    Also called TAK-491, Edarbi

    Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.

  • ValsartanDrug

    Also called Diovan

    Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.

Study groups in NCT00591578
Study groupRoleWhat they receive
Azilsartan Medoxomil 40 mg QDExperimentalNot described
Receives: Drug: Azilsartan Medoxomil
Azilsartan Medoxomil 80 mg QDExperimentalNot described
Receives: Drug: Azilsartan Medoxomil
Valsartan 320 mg QDActive comparatorNot described
Receives: Drug: Valsartan

What is being measured

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

  1. Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

    Measured: Baseline and Week 24.

Secondary outcomes (14)

  1. Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.

    The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

    Measured: Baseline and Week 24.

  2. Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

    Measured: Baseline and Week 24.

  3. Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure

    The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

    Measured: Baseline and Week 24.

  4. Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

    Measured: Baseline and Week 24.

  5. Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.

    Measured: Baseline and Week 24.

  6. Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

    Measured: Baseline and Week 24.

  7. Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.

    Measured: Baseline and Week 24.

  8. Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

    Measured: Baseline and Week 24.

  9. Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.

    Measured: Baseline and Week 24.

  10. Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

    Measured: Baseline and Week 24.

  11. Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.

    The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.

    Measured: Baseline and Week 24.

  12. Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.

    Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

    Measured: Baseline and Week 24.

  13. Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.

    Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.

    Measured: Baseline and Week 24.

  14. Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.

    Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.

    Measured: Baseline and Week 24.

Timeline

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

  1. First posted11 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionSep 2009
  4. Study completionMar 2010

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
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00591578
Sponsor's protocol ID
TAK-491_301
Other IDs
U1111-1113-9238
Status last verified
Jan 2012
First submitted
27 Dec 2007
Last updated
2 Feb 2012
Data monitoring committee
No

Publications

  • Sica D, White WB, Weber MA, Bakris GL, Perez A, Cao C, Handley A, Kupfer S. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2011 Jul;13(7):467-72. doi: 10.1111/j.1751-7176.2011.00482.x. Epub 2011 Jun 20.

    PubMed 21762358

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azilsartan Medoxomil and Valsartan in people with Hypertension, run by Takeda at 88 sites in 4 countries.

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 4 inclusion and 21 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Mexico, Chile, Peru. 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 19 Apr 2011). 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 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. (time frame: Baseline and Week 24.). 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 NCT00591578, 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 2 Feb 2012.

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