| Primary | Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit. | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-4.26± 0.60
- OG001-1.04± 0.61
|
|
| | 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 |
|---|
| | ANCOVA | | <0.001 | | Mean Difference (Net) | -3.19 | Standard Error of the Mean | 0.78 | 2-Sided | 95 | -4.73 | -1.65 | | | | No | Superiority or Other | | |
|
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits. | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Change From Baseline in Office Pulse Pressure | Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP. | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients Achieving Successful Overall Blood Pressure Control | Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control | Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control | Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response | Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline. | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Posted | | Number | | Participants | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response | Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline. | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Posted | | Number | | Participants | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |
| Secondary | Number of Patients With Total Adverse Events, Serious Adverse Events and Death | Number of patients with total adverse events, serious adverse events and death were reported. | Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization. | Posted | | Number | | Number of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. | | OG001 | Olmesartan 20 mg | Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks. |
| |