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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-9238 | Registry Identifier | WHO |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan Medoxomil 40 mg QD | Experimental |
| |
| Azilsartan Medoxomil 80 mg QD | Experimental |
| |
| Valsartan 320 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Medoxomil | Drug | Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 24. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21762358 | Result | 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. |
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Participants with essential hypertension were enrolled in one of three, once-daily (QD) treatment groups.
Participants enrolled at 103 investigative sites from 09 November 2007 to 03 September 2009 (double-blind phase) and 04 March 2009 to 13 March 2010 (open-label extension phase). A total of 984 participants were randomized into the double-blind treatment phase, of which 170 participants entered into the open-label extension phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Phase |
|
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|
| Azilsartan Medoxomil | Drug | Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks. |
|
|
| Valsartan | Drug | Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks. |
|
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| 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. |
| Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| 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. | Baseline and Week 24. |
| Glendale |
| Arizona |
| United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Tuscon | Arizona | United States |
| Beverly Hills | California | United States |
| Burbank | California | United States |
| La Jolla | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Paramount | California | United States |
| San Diego | California | United States |
| Santa Monica | California | United States |
| Spring Valley | California | United States |
| Tustin | California | United States |
| Vista | California | United States |
| Westlake Village | California | United States |
| Ridgefield | Connecticut | United States |
| Newark | Delaware | United States |
| Washington D.C. | District of Columbia | United States |
| DeLand | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Hollywood | Florida | United States |
| Inverness | Florida | United States |
| Jacksonville | Florida | United States |
| Boise | Idaho | United States |
| Chicago | Illinois | United States |
| Gurnee | Illinois | United States |
| Morton | Illinois | United States |
| Park Ridge | Illinois | United States |
| Avon | Indiana | United States |
| Bloomington | Indiana | United States |
| Crestview Hills | Kentucky | United States |
| Baltimore | Maryland | United States |
| Columbia | Maryland | United States |
| Brockton | Massachusetts | United States |
| West Yarmouth | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| City of Saint Peters | Missouri | United States |
| Florissant | Missouri | United States |
| Kansas City | Missouri | United States |
| Washington | Missouri | United States |
| Wentzville | Missouri | United States |
| Charlotte | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Shelby | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Delaware | Ohio | United States |
| Mogadore | Ohio | United States |
| Willoughby Hills | Ohio | United States |
| Zanesville | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Portland | Oregon | United States |
| Bridgeville | Pennsylvania | United States |
| Downingtown | Pennsylvania | United States |
| Jenkintown | Pennsylvania | United States |
| Lansdale | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Kingsport | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Pearland | Texas | United States |
| Rosenberg | Texas | United States |
| San Antonio | Texas | United States |
| Riverton | Utah | United States |
| Salt Lake City | Utah | United States |
| West Jordan | Utah | United States |
| Arlington | Virginia | United States |
| Burke | Virginia | United States |
| Norfolk | Virginia | United States |
| Lakewood | Washington | United States |
| Port Richard | Washington | United States |
| Menomonee Falls | Wisconsin | United States |
| Santiago | Chile |
| Temuco | Chile |
| Cabo San Lucas | Mexico |
| Colonia Escandón | Mexico |
| Culiacán | Mexico |
| Mexico City | Mexico |
| Monterrey Nuevo Leon | Mexico |
| Morelia | Mexico |
| Querétaro | Mexico |
| Chiclayo | Peru |
| Lima | Peru |
| FG001 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| FG002 | Valsartan 320 mg QD | Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Extension Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| BG001 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| BG002 | Valsartan 320 mg QD | Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Number | percentage of participants | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Number | percentage of participants | Baseline and Week 24. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Number | percentage of participants | Baseline and Week 24. |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). | 8 | 327 | 77 | 327 | ||
| EG001 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks. Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). | 5 | 329 | 74 | 329 | ||
| EG002 | Valsartan 320 mg QD | Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks. | 8 | 326 | 53 | 326 | ||
| EG003 | Open Label Extension | Azilsartan medoxomil 40 mg, tablets, orally, independent of participant's double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics). | 4 | 170 | 16 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Silent myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
For the Non-Serious Adverse Event Table, the total number of participants affected is based on the AEs with ≥5% in each phase, calculated separately.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
| C521273 | azilsartan |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
| Between 45 and 64 years (Double Blind Phase) |
|
| ≥65 years (Double Blind Phase) |
|
| <45 years (Open Label Phase) |
|
| Between 45 and 64 years (Open Label Phase) |
|
| ≥65 years (Open Label Phase) |
|
| Male (Double Blind Phase) |
|
| Female (Open Label Phase) |
|
| Male (Open Label Phase) |
|
| ANCOVA |
| <0.001 |
Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure. |
| Mean Difference (Final Values) |
| -4.03 |
| 2-Sided |
| 95 |
| -6.01 |
| -2.06 |
| No |
| Superiority or Other |
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