| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement. | Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. | | OG003 | VAL + AHU 50 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks. | | OG004 | VAL 320 mg | Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks. | | OG005 | LCZ 400 mg | Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks. | | OG006 | Placebo | Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks. |
| | Units | Counts |
|---|
| Participants | - OG000143
- OG001144
- OG002141
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-20.89± 1.22
- OG001-23.55± 1.21
- OG002-21.26± 1.23
- OG003
|
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| |
| Secondary | Change From Baseline in Mean Diastolic Blood Pressure (msDBP) | Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement. | Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP) | 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. A negative change from baseline indicates improvement. | 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in Daytime maSBP and maDBP | Twenty four hour ABPM was performed twice during 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. A negative change from baseline indicates improvement. | 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in Nighttime maSBP and maDBP | 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. A negative change from baseline indicates improvement. | 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 and 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in Mean Sitting Pulse Pressure | Pulse rate measurements were performed. A negative change from baseline indicates improvement. | Only participants of the full analysis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
|
| Secondary | Change From Baseline in Mean Ambulatory Pulse Pressure | Pulse rate measurements were performed. A negative change from baseline indicates improvement. | 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. | | OG003 | VAL + AHU 50 mg |
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| Secondary | Change From Baseline in maSBP and maDBP in Dippers | Twenty four hour ABPM was performed twice during 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 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in maSBP and maDBP 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 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age | Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement. | Only participants of the full analysuis set (FAS), who were < 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age | Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement. | Only participants of the full analysuis set (FAS), who were >= 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline, 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age | 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. A negative change from baseline indicates improvement. | A subset of randomized participants, who were leass than 65 years of age and 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age | 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. A negative change from baseline indicates improvement. | A subset of randomized participants, who were >= 65 years of age and 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 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. |
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| Secondary | Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response | Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline. | Only participants of the full analysuis set (FAS), who had week 8 measurements, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication. | Posted | | Number | | Number of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | |
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| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Death | Adverse event monitoring was conducted throughout the study. | Safety Analysis Set: The safety analysis set included all randomized participants who received at least one dose of study medication. | Posted | | Number | | Number of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | VAL + AHU 400 mg | Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. | | OG001 | VAL + AHU 200 mg | Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. | | OG002 | VAL + AHU 100 mg | Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. | | OG003 | VAL + AHU 50 mg |
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