HypertensionPhase 2NCT00362115
Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
A Phase 2 study testing Azilsartan Medoxomil and Olmesartan in people with Hypertension, run by Takeda at 54 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 54 sitesin 4 countries
- Study dates
- May 2006to Dec 2006
- Phase
- Phase 2
- 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
- Mild to moderate uncomplicated essential hypertension.
- 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.
- Must be in good health as determined by a physician.
- The subject has clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
- The subject is willing to discontinue current antihypertensive medications at Screening Day minus 21.
Who cannot join
- Diastolic blood pressure less than 95 or greater than 114 mmHg at Placebo Run-in Day minus 14 or Randomization visit, or systolic blood pressure greater than 180 mm Hg.
- Decrease of more than or equal to 8 mm Hg in clinic diastolic blood pressure between Placebo Run-in Day minus 14 and Randomization visit.
- Has taken within 7 days prior to placebo run-in, or is expected to take medications known to affect blood pressure and 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, including:
- Hypersensitive to angiotensin II receptor blockers.
- History of an acute myocardial infarction within 12 months prior to Screening, history of coronary revascularization within 6 months prior to Screening, or any history of heart failure, post-myocardial infarction angina, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular block, left bundle branch block, atrial fibrillation or flutter).
Show all 17Show fewer
- Secondary hypertension of any etiology.
- Upper arm circumference less than 24 or greater than 42 cm.
- Works night (3rd) shift (defined as 11pm to 7am).
- Non-compliant (less than 80%) with study medication during Placebo Run-in period.
- Significant, moderate to severe renal dysfunction (confirmed by serum creatinine of greater than 2 mg per dl or disease (including renal artery stenosis or known nephrotic proteinuria).
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) 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 include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin).
- Type 1 or uncontrolled type 2 diabetes mellitus (confirmed by glycosylated hemoglobin greater than 9.5%).
- Alanine transaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- 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.
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
United States46 sites
Study site
Anderson, South Carolina
Study site
Atlanta, Georgia
Study site
Auburn, Maine
Study site
Austin, Texas
Study site
Binghamtom, New York
Study site
Bristol, Tennessee
Study site
Burlington, North Carolina
Study site
Carmichael, California
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Concord, North Carolina
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Euless, Texas
Study site
Evansville, Indiana
Study site
Hickory, North Carolina
Study site
Hollywood, Florida
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Lakewood, Washington
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Madison, Wisconsin
Study site
Melbourne, Florida
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
Mt. Pleasant, South Carolina
Study site
North Richland Hills, Texas
Study site
Oklahoma City, Oklahoma
Study site
Ozark, Alabama
Study site
Pembroke Pines, Florida
Study site
Pinellas Park, Florida
Study site
Renton, Washington
Study site
Rochester, New York
Study site
Salisbury, North Carolina
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Shawnee Mission, Kansas
Study site
Simpsonville, South Carolina
Study site
Stamford, Connecticut
Study site
Trenton, New Jersey
Study site
Trumbull, Connecticut
Study site
Tustin, California
Study site
Waterbury, Connecticut
Study site
Winston-Salem, North Carolina
Mexico4 sites
Study site
Guadalajara, Jal
Study site
Mexico City
Study site
Monterrey Nuevo Leon
Study site
Morelia, Michoacan
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with 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. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. 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 hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy.
Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated 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 and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at approximately 24 and 36 hour intervals.
- Conditions
- Hypertension
- Being tested
- Azilsartan Medoxomil, Olmesartan, Placebo
- Keywords
- hypertension, blood pressure, diastolic blood pressure, drug therapy
- 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 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan MedoxomilDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan MedoxomilDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan MedoxomilDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan MedoxomilDrug
Also called TAK-491, Edarbi
Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
OlmesartanDrug
Also called Benicar
Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
PlaceboDrug
Matching placebo tablets, orally, once daily for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan Medoxomil 5 mg QD | Experimental | Not described Receives: Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 10 mg QD | Experimental | Not described Receives: Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 20 mg QD | Experimental | Not described Receives: Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 40 mg QD | Experimental | Not described Receives: Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 80 mg QD | Experimental | Not described Receives: Drug: Azilsartan Medoxomil |
| Olmesartan 20 mg QD | Active comparator | Not described Receives: Drug: Olmesartan |
| Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure.
The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
Measured: Baseline and Week 8.
Secondary outcomes (19)
Change From Baseline in Sitting Clinic Systolic Blood Pressure.
The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
Measured: Baseline and Week 8
Change From Baseline in Standing Clinic Systolic Blood Pressure.
The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.
Measured: Baseline and Week 8.
Change From Baseline in Standing Clinic Diastolic Blood Pressure.
The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.
Measured: Baseline and Week 8.
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 8 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 8.
Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in 24-hour mean diastolic blood pressure measured at week 8 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 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 8 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 8.
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 8 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 8.
Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.
Measured: Baseline and Week 8.
Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.
Measured: Baseline and Week 8.
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 8 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 8
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 8 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 8.
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 8 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 8.
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 8 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 8.
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 8 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 8.
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 8 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 8.
Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.
Measured: Baseline and Week 8.
Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.
Measured: Baseline and Week 8.
Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.
Measured: Baseline and Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2006
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- VP Clinical Science Strategy, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362115
- Sponsor's protocol ID
- 01-05-TL-491-005
- Other IDs
- U1111-1113-8783
- Status last verified
- Mar 2011
- First submitted
- 7 Aug 2006
- 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 Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-491 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension
- ClinicalTrials.gov ID
- NCT00362115
- Acronym / sponsor ID
- 01-05-TL-491-005
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure, diastolic blood pressure, drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Aug 2006 (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.
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with 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. Data from the Framingham Heart study suggest that the lifetime risk of developing hypertension among 55- to 65-year-old individuals is greater than 90%. 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 hypertension treatments, hypertension remains inadequately controlled; only about one third of patients continue to maintain control successfully. To help address these matters, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure proposes a more aggressive intervention to hypertension management with more potent antihypertensive agents and combination therapy.
Takeda Global Research \& Development Center, Inc. is developing TAK-491 (azilsartan medoxomil) to treat mild to moderate essential hypertension. Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed to the activity moiety, azilsartan, which is an angiotensin II type 1 receptor antagonist. This study is proposed to evaluate the efficacy, safety and tolerability of multiple doses of azilsartan medoxomil at five dose levels in subjects with mild to moderate uncomplicated 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 and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram Outside of the study center, participants will be required to wear an ambulatory blood pressure monitoring device at approximately 24 and 36 hour intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Azilsartan Medoxomil 5 mg QD | Experimental | Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 10 mg QD | Experimental | Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 20 mg QD | Experimental | Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 40 mg QD | Experimental | Drug: Azilsartan Medoxomil |
| Azilsartan Medoxomil 80 mg QD | Experimental | Drug: Azilsartan Medoxomil |
| Olmesartan 20 mg QD | Active comparator | Drug: Olmesartan |
| Placebo QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild to moderate uncomplicated essential hypertension.
- 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.
- Must be in good health as determined by a physician.
- The subject has clinical laboratory evaluations within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.
- The subject is willing to discontinue current antihypertensive medications at Screening Day minus 21.
Key exclusion criteria (17 listed)
- Diastolic blood pressure less than 95 or greater than 114 mmHg at Placebo Run-in Day minus 14 or Randomization visit, or systolic blood pressure greater than 180 mm Hg.
- Decrease of more than or equal to 8 mm Hg in clinic diastolic blood pressure between Placebo Run-in Day minus 14 and Randomization visit.
- Has taken within 7 days prior to placebo run-in, or is expected to take medications known to affect blood pressure and 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, including:
- Hypersensitive to angiotensin II receptor blockers.
- History of an acute myocardial infarction within 12 months prior to Screening, history of coronary revascularization within 6 months prior to Screening, or any history of heart failure, post-myocardial infarction angina, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
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 MedoxomilAlso: TAK-491, EdarbiAzilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Azilsartan Medoxomil 5 mg QD |
| Azilsartan MedoxomilAlso: TAK-491, EdarbiAzilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Azilsartan Medoxomil 10 mg QD |
| Azilsartan MedoxomilAlso: TAK-491, EdarbiAzilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Azilsartan Medoxomil 20 mg QD |
| Azilsartan MedoxomilAlso: TAK-491, EdarbiAzilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Azilsartan Medoxomil 40 mg QD |
| Azilsartan MedoxomilAlso: TAK-491, EdarbiAzilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Azilsartan Medoxomil 80 mg QD |
| OlmesartanAlso: BenicarOlmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Olmesartan 20 mg QD |
| PlaceboMatching placebo tablets, orally, once daily for up to 8 weeks. | Drug | Placebo QD |
Primary outcome
Change From Baseline in Sitting Clinic Diastolic Blood Pressure.
Time frame: Baseline and Week 8.
The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.
19 secondary outcomes
Change From Baseline in Sitting Clinic Systolic Blood Pressure.
Time frame: Baseline and Week 8
Change From Baseline in Standing Clinic Systolic Blood Pressure.
Time frame: Baseline and Week 8.
Change From Baseline in Standing Clinic Diastolic Blood Pressure.
Time frame: Baseline and Week 8.
Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8
Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8
Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Time frame: Baseline and Week 8.
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.
VP Clinical Science Strategy study director
Takeda
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azilsartan Medoxomil and Olmesartan in people with Hypertension, run by Takeda at 54 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 5 inclusion and 17 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 54 sites in United States, Mexico, Argentina, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sitting Clinic Diastolic Blood Pressure. (time frame: Baseline and Week 8.). 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.