| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension. | Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG000164.8± 4.54
- OG001166.2± 5.23
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| | Week 8 | | |
| | 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 |
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| | ANCOVA | | 0.295 | | Least Square Mean Difference | -1.6 | | | 2-Sided | 95 | -4.61 | 1.40 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension. | Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Secondary | Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8 | To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension. | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable. | Posted | | Number | | percentage of patients | | At Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Secondary | Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8 | To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension. | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable. | Posted | | Number | | percentage of responders | | At Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Secondary | Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8 | To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension. | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable. | Posted | | Mean | Standard Deviation | ng/mL/h | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Secondary | Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 | To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension. | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable. | Posted | | Mean | Standard Deviation | ng/L | | Baseline to Week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Other Pre-specified | Completers Analysis for Change From Baseline in MSSBP at Week 8 | To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period. | The analysis included ITT patients who completed the double-blind treatment period [those patients with a final observation at week 8, also known as observed cases (OC)]. This analysis differed from the ITT-LOCF analysis, in that it did not include patients who discontinued from the trial prematurely. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Other Pre-specified | Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8 | To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.) | The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Baseline through week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Other Pre-specified | Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP). | To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension. | Patients who were willing to participate in the Ambulatory Blood Pressure Monitoring (ABPM) substudy and who met the study inclusion and exclusion criteria for randomization. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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| Other Pre-specified | Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP) | To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension. | Patients who were willing to participate in the ABPM substudy and who met the study inclusion and exclusion criteria for randomization. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to week 8 | | | | ID | Title | Description |
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| OG000 | Valsartan/Aliskiren | For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration). | | OG001 | Valsartan | For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration). |
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