| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg | Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements. | Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had 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 | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-20.48± 0.61
- OG001-18.15± 0.61
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| | 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 | | <0.001 | | least Square Means net difference | -2.33 | Standard Error of the Mean | 0.85 | | 95 | -4.00 | -0.66 | | | | Yes | Non-Inferiority or Equivalence | The statistical test was made at a one-sided significance level of 0.025. | |
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| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg | Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements | Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG001 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement | Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments | Posted | | Mean | Standard Error | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Change From Baseline in Office Pulse Pressure (msPP) | Four separate sitting BP measurements should be obtained with a full two minute interval between measurements. | Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had 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 | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory Blood Pressure | In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study. | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers. | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | Posted | | Mean | Standard Deviation | mmHg | | baseline, 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | |
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| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers. | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | Posted | | Mean | Standard Deviation | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | |
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| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers. | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | Posted | | Mean | Standard Deviation | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | |
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| Secondary | Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers. | Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement | A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed | Posted | | Mean | Standard Deviation | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | |
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| Secondary | Number of Patients Achieving Successful Blood Pressure Control | Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg. | Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments. | Posted | | Number | | Number of participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Change From Baseline in Ambulatory Pulse Pressure | Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period. | Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments. | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Number of Responders | Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline) | Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments | 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 LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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| Secondary | Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. | Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received. | Posted | | Number | | Participants | | baseline, 8 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 200 mg | Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily. | | OG001 | LCZ696 400 mg | Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken. | | OG002 | Olmesartan 20 mg | Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily. |
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