| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. | Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-18.21± 0.702
- OG001-20.18± 0.704
- OG002-13.20± 0.700
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 | A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Posted | | Number | | Percentage of participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Percentage of Participants Achieving a Successful msSBP Response | Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Posted | | Number | | Percentage of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Percentage of Participants Achieving a Successful msDBP Response | Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Posted | | Number | | Percentage of participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Change From Baseline in maSBP and maDBP for Daytime/Nighttime | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Change From Baseline in Office Pulse Pressure | Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure | Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants. | The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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| Secondary | Number of Patients With Adverse Events, Serious Adverse Events and Death | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. | Safety Set. The safety set included aqll participants who had received study medication. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks | | OG001 | LCZ696 400 mg | LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks | | OG002 | Olmesartan 20 mg | Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks |
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