| Primary | Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure | The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
| | | Title | Denominators | Categories |
|---|
| Week 6 (n=295; n=292) | | | Title | Measurements |
|---|
| - OG000-35.1± 0.97
- OG001-29.5± 0.98
|
| | Week 10 (n=295; n=292) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data. | ANCOVA | | <0.001 | Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level. | Mean Difference (Final Values) | -5.6 | | | 2-Sided | 95 | -8.3 | -2.9 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure | The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring. | The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring. | The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring | The change in the 12-hour mean systolic blood pressure measured at each visit including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring. | The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit 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, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, Week 6 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease | Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as <140mm Hg without diabetes or chronic kidney disease or <130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Number | | percentage of participants | | Week 2, Week 4, Week 6, Week 8 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment. |
|
| Secondary | Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease. | Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as <90 mm Hg for participants without diabetes or chronic kidney disease or <80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Number | | percentage of participants | | Week 2, Week 4, Week 6, Week 8 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD | |
|
| Secondary | Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease | Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease or <130/80 mm Hg for participants with diabetes or chronic kidney disease[GFR <60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) >200 mg albumin/g creatinine at Screening.] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements. | Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward. | Posted | | Number | | percentage of participants | | Week 2, Week 4, Week 6, Week 8 and Week 10. | | | | ID | Title | Description |
|---|
| OG000 | Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD | Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment. | | OG001 | Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD |
|