HypertensionPhase 3NCT00695955
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
A Phase 3 study testing Azilsartan medoxomil with or without add-on chlorthalidone and Azilsartan medoxomil with or without add-on hydrochlorothiazide in people with Hypertension, run by Takeda at 41 sites in 3 countries.
Trial summary
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals 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 with or without add-on chlorthalidone and Azilsartan medoxomil with or without add-on hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 41 sitesin 3 countries
- Study dates
- Jun 2007to May 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
- Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
- Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.
Who cannot join
- Systolic blood pressure greater than 185 mm Hg.
- Expected to take angiotensin II receptor blockers other than the study drug.
- Taking more than 2 antihypertensive agents.
- Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
- Recent history of major cardiovascular event.
- History of moderate to severe heart failure or hypertensive encephalopathy.
Show all 18Show fewer
- Clinically significant cardiac conduction defects.
- Secondary hypertension of any etiology.
- Known or suspected unilateral or bilateral renal artery stenosis.
- Severe renal dysfunction or disease.
- History of drug abuse or a history of 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..
- Uncontrolled diabetes mellitus.
- Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Serum potassium level of greater than the upper limit of normal.
- Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to enrollment.
- Any other serious disease or condition.
- Randomized in a previous azilsartan medoxomil study.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States39 sites
Study site
Akron, Ohio
Study site
Anderson, South Carolina
Study site
Arlington, Texas
Study site
Atlanta, Georgia
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Bristol, Tennessee
Study site
Brooklyn Center, Minnesota
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Colorado Springs, Colorado
Study site
Fort Lauderdale, Florida
Study site
Hollywood, Florida
Study site
Jacksonville, Florida
Study site
Long Beach, California
Study site
Miami, Florida
Study site
Mogadore, Ohio
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
Norfolk, Virginia
Study site
North Richland Hills, Texas
Study site
Oklahoma City, Oklahoma
Study site
Olive Branch, Mississippi
Study site
Ozark, Alabama
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pinellas Park, Florida
Study site
Raleigh, North Carolina
Study site
Rochester, New York
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
Santa Rosa, California
Study site
Simpsonville, South Carolina
Study site
Spring Valley, California
Study site
Springdale, Ohio
Study site
Tallassee, Alabama
Study site
Trumbull, Connecticut
Study site
Waterbury, Connecticut
Study site
Winston-Salem, North Carolina
About this study
Official title: A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals 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.
Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.
- Conditions
- Hypertension
- Being tested
- Azilsartan medoxomil with or without add-on chlorthalidone, Azilsartan medoxomil with or without add-on hydrochlorothiazide
- 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 with or without add-on chlorthalidoneDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Azilsartan medoxomil with or without add-on hydrochlorothiazideDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan Medoxomil | Experimental | Not described Receives: Drug: Azilsartan medoxomil with or without add-on chlorthalidone; Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Measured: 56 weeks.
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Measured: 56 weeks.
Secondary outcomes (4)
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: 52 weeks
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: 52 weeks
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: 52 weeks.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Measured: 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Executive Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695955
- Sponsor's protocol ID
- 01-05-TL-491-006
- Other IDs
- U1111-1113-8874
- Status last verified
- Mar 2011
- First submitted
- 10 Jun 2008
- Last updated
- 19 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of TAK-491 in Subjects With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00695955
- Acronym / sponsor ID
- 01-05-TL-491-006
- Conditions
- Hypertension
- Keywords
- Essential Hypertension, Cardiovascular Disease, High Blood Pressure, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 19 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
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.
Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azilsartan Medoxomil | Experimental | Drug: Azilsartan medoxomil with or without add-on chlorthalidone, Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diastolic blood pressure greater than or equal to 95 mm Hg and less than or equal to 119 mm Hg. For diabetic subjects and subjects with chronic kidney disease, diastolic blood pressure must be greater than or equal to 85 mm Hg and less than or equal to109 mm Hg).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating.
- Clinical laboratory evaluations within the reference range for or deemed not clinically significant by the investigator.
Key exclusion criteria (18 listed)
- Systolic blood pressure greater than 185 mm Hg.
- Expected to take angiotensin II receptor blockers other than the study drug.
- Taking more than 2 antihypertensive agents.
- Hypersensitive to angiotensin II receptor blockers, thiazide-type diuretics or sulfonamide-derived compounds.
- Recent history of major cardiovascular event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilsartan medoxomil with or without add-on chlorthalidoneAlso: TAK-491, EdarbiAzilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved. | Drug | Azilsartan Medoxomil |
| Azilsartan medoxomil with or without add-on hydrochlorothiazideAlso: TAK-491, EdarbiAzilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved. | Drug | Azilsartan Medoxomil |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Time frame: 56 weeks.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Time frame: 56 weeks.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
4 secondary outcomes
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Time frame: 52 weeks
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Time frame: 52 weeks
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Time frame: 52 weeks.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Time frame: 52 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Medical Director Clinical Science study director
Takeda
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azilsartan medoxomil with or without add-on chlorthalidone and Azilsartan medoxomil with or without add-on hydrochlorothiazide in people with Hypertension, run by Takeda at 41 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 3 inclusion and 18 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Chile, Mexico. 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?
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1. (time frame: 56 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2011.