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AzTrials

HypertensionPhase 3NCT00696241

Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

A Phase 3 study testing Azilsartan medoxomil and olmesartan and Olmesartan in people with Hypertension, run by Takeda at 85 sites in 3 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 determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan 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 olmesartan and Olmesartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,275 participants
Where
85 sitesin 3 countries
Study dates
Jun 2007to Oct 2008
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

  • Has 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 greater than or equal to 130 mm Hg and less than or equal to 170 mm Hg 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.
  • The subject is 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.
  • Baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality.
  • History 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, third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or atrial flutter).
  • Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
  • Secondary hypertension of any etiology.
Show all 19Show fewer
  • Is noncompliant (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/min/1.73 m2) at Screening.
  • Known or suspected unilateral or bilateral renal artery stenosis.
  • History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within the past 2 years.
  • 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 I squamous cell carcinoma of the skin).
  • Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening.
  • Alanine aminotransferase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening.
  • Hyperkalemia (defined as serum potassium greater than the upper limit of normal per the central laboratory) at Screening.
  • Upper arm circumference less than 24 cm or greater than 42 cm.
  • Works night (3rd) shift (defined as 11 PM to 7 AM).
  • Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening.
  • 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

85 sites in 3 countries.

85 sites in 3 countries

United States80 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Altoona, Pennsylvania

  • Study site

    Auburn, Maine

  • Study site

    Augusta, Georgia

  • Study site

    Benzonia, Michigan

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Brooklyn, New York

  • Study site

    Burke, Virginia

  • Study site

    Burlington, North Carolina

  • Study site

    Carmichael, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Chelsea, Michigan

  • Study site

    Chicago, Illinois

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Draper, Utah

  • Study site

    Erlanger, Kentucky

  • Study site

    Farmington, Connecticut

  • Study site

    Fountain Valley, California

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Kettering, Ohio

  • Study site

    Lake Jackson, Texas

  • Study site

    Lawrenceville, Georgia

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Gatos, California

  • Study site

    Lyndhurst, Ohio

  • Study site

    Madison, Wisconsin

  • Study site

    Marion, Ohio

  • Study site

    Melbourne, Florida

  • Study site

    Melrose Park, Illinois

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Naperville, Illinois

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Tazewell, Tennessee

  • Study site

    Norfolk, Virginia

  • Study site

    Norman, Oklahoma

  • Study site

    North Richland Hills, Texas

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orangevale, California

  • Study site

    Orangevale, New York

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Raleigh, North Carolina

  • Study site

    Reading, Pennsylvania

  • Study site

    Rochester, New York

  • Study site

    Round Lake Beach, Illinois

  • Study site

    Sacramento, California

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Sarasota, Florida

  • Study site

    Simpsonville, South Carolina

  • Study site

    Spring Valley, California

  • Study site

    St. Petersburg, Florida

  • Study site

    Statesville, North Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Taylors, South Carolina

  • Study site

    Tempe, Arizona

  • Study site

    Tempe, Arkansas

  • Study site

    Trenton, New Jersey

  • Study site

    Tustin, California

  • Study site

    Valparaiso, Indiana

  • Study site

    West Yarmouth, Massachusetts

  • Study site

    Westlake Village, California

  • Study site

    Wichita, Kansas

  • Study site

    Wildwood Crest, New Jersey

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Mexico3 sites

  • Study site

    Aguascalientes

  • Study site

    Mexico City

  • Study site

    San Luis Potosí City

Other trials in Mexico

Argentina2 sites

  • Study site

    Provincia de Buenos Aires

  • Study site

    Provincia de Cordoba

Other trials in Argentina

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects With Essential Hypertension

The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan 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, 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.

TAK-491 (azilsartan medoxomil) is an angiotensin II receptor blocker and this study is being conducted to evaluate the efficacy and safety of oral azilsartan medoxomil compared to placebo and olmesartan in subjects with essential hypertension.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 11 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting blood pressure and pulse, body height and weight, physical examinations and electrocardiograms. Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at 24 hour intervals.

Conditions
Hypertension
Being tested
Azilsartan medoxomil and olmesartan, Olmesartan, Placebo
Keywords
Essential Hypertension, Cardiovascular Disease, High Blood Pressure, Drug Therapy
Medical subject headings
Hypertension, Essential Hypertension, Cardiovascular Diseases

What participants receive

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

  • Azilsartan medoxomil and olmesartanDrug

    Also called TAK-491, Edarbi

    Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.

  • Azilsartan medoxomil and olmesartanDrug

    Also called TAK-491, Edarbi

    Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.

  • Azilsartan medoxomil and olmesartanDrug

    Also called TAK-491, Edarbi

    Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

  • OlmesartanDrug

    Also called Benicar®

    Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

  • PlaceboDrug

    Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.

Study groups in NCT00696241
Study groupRoleWhat they receive
Azilsartan Medoxomil 20 mg QDExperimentalNot described
Receives: Drug: Azilsartan medoxomil and olmesartan
Azilsartan Medoxomil 40 mg QDExperimentalNot described
Receives: Drug: Azilsartan medoxomil and olmesartan
Azilsartan Medoxomil 80 mg QDExperimentalNot described
Receives: Drug: Azilsartan medoxomil and olmesartan
Olmesartan 40 mg QDActive comparatorNot described
Receives: Drug: Olmesartan
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

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

    The change in 24-hour mean systolic blood pressure measured at week 6 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 6.

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 6 relative to baseline.

    Measured: Baseline and Week 6.

  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 6 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 6.

  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 6 relative to baseline.

    Measured: Baseline and Week 6.

  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 6 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 6.

  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 diastolic blood pressure measured at week 6 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 6.

  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 6 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 6.

  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 6 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 6.

  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 6 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 6.

  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 6 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 6.

  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 6 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 6.

  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 6 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 6.

  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 6, 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 6.

  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 6, 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 6.

  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 6, 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 6.

Timeline

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

  1. First posted12 Jun 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

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
1,275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00696241
Sponsor's protocol ID
01-05-TL-491-008
Other IDs
U1111-1113-8905
Status last verified
Jul 2011
First submitted
10 Jun 2008
Last updated
29 Jul 2011
Data monitoring committee
No

Publications

  • White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011 Mar;57(3):413-20. doi: 10.1161/HYPERTENSIONAHA.110.163402. Epub 2011 Jan 31.

    PubMed 21282560

  • Bakris GL, Sica D, Weber M, White WB, Roberts A, Perez A, Cao C, Kupfer S. The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure. J Clin Hypertens (Greenwich). 2011 Feb;13(2):81-8. doi: 10.1111/j.1751-7176.2010.00425.x.

    PubMed 21272195

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azilsartan medoxomil and olmesartan and Olmesartan in people with Hypertension, run by Takeda at 85 sites in 3 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 19 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 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Mexico, Argentina. 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. Some participants in this study may receive a placebo. 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 the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring. (time frame: Baseline and Week 6.). 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 NCT00696241, which also lists 2 linked publications.

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 29 Jul 2011.

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