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To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.
This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aml + olm + hctz | Experimental | amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Amlodipine 5 mg tablets , Daily for 3 weeks; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment | Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0. | week 0 - week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment | 24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP | week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) |
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Inclusion Criteria:
Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.
Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide | Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| amlodipine / olmesartan medoxomil combination | Drug | amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg |
|
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| Hydrochlorothiazide | Drug | hydrochlorothiazide tablets, 12.5 mg or 25 mg. |
|
| Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment |
Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP |
| week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) |
| Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks | change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. | week 0 - weeks 3, 6, 9, 12, 15, 18 |
| Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks | change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. | week 0 - weeks 3, 6, 9, 12, 15, 18 |
| Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3 | week 0 - week 3 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6 | week 0 - week 6 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9 | week 0 - week 9 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | week 0 - week 12 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15 | week 0 - week 15 |
| Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18 | week 0 - week 18 |
| Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions | number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3 | week 0 - week 3 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6 | week 0 - week 6 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9 | week 0 - week 9 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | week 0 - week 12 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15 | week 0 - week 15 |
| Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18 | week 0 - week 18 |
| Sylmar |
| California |
| United States |
| Tustin | California | United States |
| Aventura | Florida | United States |
| DeLand | Florida | United States |
| Hialeah | Florida | United States |
| Pembroke Pines | Florida | United States |
| Avon | Indiana | United States |
| Indianapolis | Indiana | United States |
| Las Vegas | Nevada | United States |
| New Windsor | New York | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Charleston | South Carolina | United States |
| Greer | South Carolina | United States |
| Taylors | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Burke | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aml + Olm + Hctz | amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled. |
| 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 Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Stage of hypertension | Stage 1 or Stage 2 Hypertension. Stage 1 = Blood pressure > 140/90 mm Hg. Stage 2 = systolic >160 mm Hg or diastolic > 100 mm Hg | Number | participants |
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| Body mass index | Mean | Standard Deviation | mg/m2 |
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| Mean 24-hour ambulatory diastolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Mean 24-hour ambulatory systolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Pulse rate | Mean | Standard Deviation | beats per minute |
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| Seated Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Seated Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Years with diabetes | Mean | Standard Deviation | years |
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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 Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment | Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0. | ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12. | Posted | Apr 2010 | Mean | Standard Error | mm Hg | week 0 - week 12 |
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| Secondary | Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment | 24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP | Posted | Apr 2010 | Mean | Standard Error | mm Hg | week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) |
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| Secondary | Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment | Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP | Posted | Apr 2010 | Mean | Standard Error | mm Hg | week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour) |
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| Secondary | Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks | change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. | Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164. | Posted | Apr 2010 | Mean | Standard Error | mm Hg | week 0 - weeks 3, 6, 9, 12, 15, 18 |
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| Secondary | Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks | change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18. | Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164. | Posted | Apr 2010 | Mean | Standard Error | mm Hg | week 0 - weeks 3, 6, 9, 12, 15, 18 |
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| Secondary | Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12 | number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3 | Posted | Apr 2010 | Number | participants | week 0 - week 3 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6 | Posted | Apr 2010 | Number | participants | week 0 - week 6 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9 | Posted | Apr 2010 | Number | participants | week 0 - week 9 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15 | Posted | Apr 2010 | Number | participants | week 0 - week 15 |
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| Secondary | Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18 | number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18 | Posted | Apr 2010 | Number | participants | week 0 - week 18 |
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| Secondary | Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions | number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3 | Posted | Apr 2010 | Number | participants | week 0 - week 3 |
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| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6 | Posted | Apr 2010 | Number | participants | week 0 - week 6 |
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| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9 | Posted | Apr 2010 | Number | participants | week 0 - week 9 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12 | Posted | Apr 2010 | Number | participants | week 0 - week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15 | Posted | Apr 2010 | Number | participants | week 0 - week 15 |
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| Secondary | Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18 | number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18 | Posted | Apr 2010 | Number | participants | week 0 - week 18 |
|
|
Not provided
Not provided
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 | ALL - Aml + Olm + Hctz | Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required | 4 | 207 | 80 | 207 | ||
| EG001 | Start - Amlodipine 5 mg | All participants started trial on Amlodipine 5 mg. | 0 | 207 | 16 | 207 | ||
| EG002 | Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg | Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. | 0 | 195 | 15 | 195 | ||
| EG003 | Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg | Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. | 1 | 177 | 10 | 177 | ||
| EG004 | Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg | Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. | 0 | 167 | 21 | 167 | ||
| EG005 | Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg | Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. | 1 | 146 | 14 | 146 | ||
| EG006 | Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg | Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. | 2 | 101 | 4 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| presyncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by Daiichi Sankyo Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted. Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James McCarthy | Daiichi Sankyo | 732-590-3430 | jmccarthy@dsi.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000068558 | Amlodipine Besylate, Olmesartan Medoxomil Drug Combination |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068557 | Olmesartan Medoxomil |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 24-hour mean DBP change from baseline |
| |||||
| daytime mean DBP change from baseline |
| |||||
| nighttime mean DBP change from baseline |
| |||||
| last 6 hour mean DBP change from baseline |
| |||||
| last 4 hour mean DBP change from baseline |
| |||||
| last 2 hour mean DBP change from baseline |
|
|
| Title | Denominators | Categories |
|---|
| daytime mean SBP change from baseline |
| |||||
| nighttime mean SBP change from baseline |
| |||||
| last 6 hours mean SBP change from baseline |
| |||||
| last 4 hours mean SBP change from baseline |
| |||||
| last 2 hours mean SBP change from baseline |
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean 24-hour BP <135/85 |
| |||||
| mean 24-hour BP <130/80 |
| |||||
| mean 24-hour BP <125/75 |
| |||||
| mean 24-hour BP <120/80 |
| |||||
| mean 24-hour SBP <135 |
| |||||
| mean 24-hour SBP <130 |
| |||||
| mean 24-hour SBP <125 |
| |||||
| mean 24-hour SBP <120 |
| |||||
| mean 24-hour DBP <85 |
| |||||
| mean 24-hour DBP <80 |
| |||||
| mean 24-hour DBP <75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean daytime BP < 135/85 |
| |||||
| mean daytime BP < 130/80 |
| |||||
| mean daytime BP < 125/75 |
| |||||
| mean daytime BP < 120/80 |
| |||||
| mean daytime SBP < 135 |
| |||||
| mean daytime SBP < 130 |
| |||||
| mean daytime SBP < 125 |
| |||||
| mean daytime SBP < 120 |
| |||||
| mean daytime DBP < 85 |
| |||||
| mean daytime DBP < 80 |
| |||||
| mean daytime DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean nighttime BP < 135/85 |
| |||||
| mean nighttime BP < 130/80 |
| |||||
| mean nighttime BP < 125/75 |
| |||||
| mean nighttime BP < 120/80 |
| |||||
| mean nighttime BP < 120/70 |
| |||||
| mean nighttime SBP < 135 |
| |||||
| mean nighttime SBP < 130 |
| |||||
| mean nighttime SBP < 125 |
| |||||
| mean nighttime SBP < 120 |
| |||||
| mean nighttime DBP < 85 |
| |||||
| mean nighttime DBP < 80 |
| |||||
| mean nighttime DBP < 75 |
| |||||
| mean nighttime DBP < 70 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean last 6 hour BP < 135/85 |
| |||||
| mean last 6 hour BP < 130/80 |
| |||||
| mean last 6 hour BP < 125/75 |
| |||||
| mean last 6 hour BP < 120/80 |
| |||||
| mean last 6 hour SBP < 135 |
| |||||
| mean last 6 hour SBP < 130 |
| |||||
| mean last 6 hour SBP < 125 |
| |||||
| mean last 6 hour SBP < 120 |
| |||||
| mean last 6 hour DBP < 85 |
| |||||
| mean last 6 hour DBP < 80 |
| |||||
| mean last 6 hour DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean last 4 hour BP < 135/85 |
| |||||
| mean last 4 hour BP < 130/80 |
| |||||
| mean last 4 hour BP < 125/75 |
| |||||
| mean last 4 hour BP < 120/80 |
| |||||
| mean last 4 hour SBP < 135 |
| |||||
| mean last 4 hour SBP < 130 |
| |||||
| mean last 4 hour SBP < 125 |
| |||||
| mean last 4 hour SBP < 120 |
| |||||
| mean last 4 hour DBP < 85 |
| |||||
| mean last 4 hour DBP < 80 |
| |||||
| mean last 4 hour DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean last 2 hour BP < 135/85 |
| |||||
| mean last 2 hour BP < 130/80 |
| |||||
| mean last 2 hour BP < 125/75 |
| |||||
| mean last 2 hour BP < 120/80 |
| |||||
| mean last 2 hour SBP < 135 |
| |||||
| mean last 2 hour SBP < 130 |
| |||||
| mean last 2 hour SBP < 125 |
| |||||
| mean last 2 hour SBP < 120 |
| |||||
| mean last 2 hour DBP < 85 |
| |||||
| mean last 2 hour DBP < 80 |
| |||||
| mean last 2 hour DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| mean BP < 135/85 |
| |||||
| mean BP < 130/80 |
| |||||
| mean BP < 125/75 |
| |||||
| mean BP < 120/80 |
| |||||
| mean SBP < 135 |
| |||||
| mean SBP < 130 |
| |||||
| mean SBP < 125 |
| |||||
| mean SBP < 120 |
| |||||
| mean DBP < 85 |
| |||||
| mean DBP < 80 |
| |||||
| mean DBP < 75 |
|
|
|
|
|
|
|
|
|
|
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|
|