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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-8783 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with 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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azilsartan Medoxomil 5 mg QD | Experimental |
| |
| Azilsartan Medoxomil 10 mg QD | Experimental |
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| Azilsartan Medoxomil 20 mg QD | Experimental |
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| Azilsartan Medoxomil 40 mg QD | Experimental |
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| Azilsartan Medoxomil 80 mg QD | Experimental |
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| Olmesartan 20 mg QD | Active Comparator |
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| Placebo QD | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Medoxomil | Drug | Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 8 |
| Change From Baseline in Standing Clinic Systolic Blood Pressure. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| VP Clinical Science Strategy | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
Participants with mild to moderate uncomplicated essential hypertension were enrolled in one of seven, once-daily (QD) treatment groups.
Participants enrolled at 76 investigative sites in Argentina, Mexico, Peru and the United States from 16 May 2006 to 07 December 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan Medoxomil 5 mg QD | Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| FG001 | Azilsartan Medoxomil 10 mg QD | Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Azilsartan Medoxomil | Drug | Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
| Azilsartan Medoxomil | Drug | Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
|
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| Azilsartan Medoxomil | Drug | Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
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| Azilsartan Medoxomil | Drug | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
|
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| Olmesartan | Drug | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
|
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| Placebo | Drug | Matching placebo tablets, orally, once daily for up to 8 weeks. |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 8. |
| Ozark |
| Alabama |
| United States |
| Mesa | Arizona | United States |
| Little Rock | Arkansas | United States |
| Carmichael | California | United States |
| Long Beach | California | United States |
| San Diego | California | United States |
| Tustin | California | United States |
| Denver | Colorado | United States |
| Stamford | Connecticut | United States |
| Trumbull | Connecticut | United States |
| Waterbury | Connecticut | United States |
| Hollywood | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Miami | Florida | United States |
| Pembroke Pines | Florida | United States |
| Pinellas Park | Florida | United States |
| Atlanta | Georgia | United States |
| Evansville | Indiana | United States |
| Shawnee Mission | Kansas | United States |
| Auburn | Maine | United States |
| Trenton | New Jersey | United States |
| Binghamtom | New York | United States |
| Rochester | New York | United States |
| Burlington | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Concord | North Carolina | United States |
| Hickory | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Anderson | South Carolina | United States |
| Mt. Pleasant | South Carolina | United States |
| Simpsonville | South Carolina | United States |
| Bristol | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Euless | Texas | United States |
| North Richland Hills | Texas | United States |
| San Antonio | Texas | United States |
| Lakewood | Washington | United States |
| Renton | Washington | United States |
| Madison | Wisconsin | United States |
| BA | Argentina |
| Córdoba | Argentina |
| Ushuaia | Argentina |
| Guadalajara, Jal | Mexico |
| Mexico City | Mexico |
| Monterrey Nuevo Leon | Mexico |
| Morelia, Michoacan | Mexico |
| Lima | Peru |
| FG002 | Azilsartan Medoxomil 20 mg QD | Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| FG003 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| FG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| FG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| FG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan Medoxomil 5 mg QD | Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG001 | Azilsartan Medoxomil 10 mg QD | Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG002 | Azilsartan Medoxomil 20 mg QD | Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG003 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
| BG007 | 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 Categorical | Number | participants |
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| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8 |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full analysis set with last observation carried forward. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8 |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8 |
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| Secondary | 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. | Full Analysis Set. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 8. |
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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 5 mg QD | Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 1 | 65 | 7 | 65 | ||
| EG001 | Azilsartan Medoxomil 10 mg QD | Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 1 | 64 | 7 | 64 | ||
| EG002 | Azilsartan Medoxomil 20 mg QD | Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 0 | 64 | 13 | 64 | ||
| EG003 | Azilsartan Medoxomil 40 mg QD | Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 1 | 62 | 8 | 62 | ||
| EG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 0 | 64 | 7 | 64 | ||
| EG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. | 1 | 63 | 7 | 63 | ||
| EG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. | 1 | 63 | 7 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypertensive Heart Disease | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oesophageal Spasm | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
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 |
| C437965 | olmesartan |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
Not provided
Not provided
| Between 45 and 64 years |
|
| ≥65 years |
|
| Male |
|
| ANCOVA |
| 0.0008 |
P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. |
| Mean Difference (Final Values) |
| -5.3 |
| 2-Sided |
| 95 |
| -8.33 |
| -2.20 |
| No |
| Superiority or Other |
| ANCOVA | 0.0188 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -3.7 | 2-Sided | 95 | -6.73 | -0.61 | No | Superiority or Other |
| ANCOVA | 0.0003 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -5.7 | 2-Sided | 95 | -8.80 | -2.63 | No | Superiority or Other |
| ANCOVA | 0.0177 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -3.7 | 2-Sided | 95 | -6.77 | -0.65 | No | Superiority or Other |
| ANCOVA | 0.8550 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | 0.3 | 95 | -2.72 | 3.27 | No | Superiority or Other |
| ANCOVA | 0.1719 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -2.1 | 2-Sided | 95 | -5.08 | 0.91 | No | Superiority or Other |
| ANCOVA | 0.7469 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -3.49 | 2.50 | No | Superiority or Other |
| ANCOVA | 0.1001 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -5.55 | 0.49 | No | Superiority or Other |
| ANCOVA | 0.7294 | P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -3.52 | 2.47 | No | Superiority or Other |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| Azilsartan Medoxomil 40 mg QD |
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| Azilsartan Medoxomil 40 mg QD |
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| Azilsartan Medoxomil 40 mg QD |
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|
| Azilsartan Medoxomil 40 mg QD |
Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG004 | Azilsartan Medoxomil 80 mg QD | Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG005 | Olmesartan 20 mg QD | Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks. |
| OG006 | Placebo QD | Matching placebo tablets, orally, once daily for up to 8 weeks. |
|
|
|