| Primary | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement. | Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind period. | Posted | | Geometric Mean | 95% Confidence Interval | ratio: endpoint/baseline (pg/mL) | | Baseline, 12 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.83(0.68 to 1.01)
- OG0011.08(0.89 to 1.32)
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| Secondary | Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP) | Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Geometric Mean | 95% Confidence Interval | ratio: endpoint/baseline (pg/mL) | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP) | Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Geometric Mean | 95% Confidence Interval | ratio: endpoint/baseline (nmol/L) | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | cm | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | ml | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | Percent ejection fraction | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Left Ventricular Mass | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | grams (g) | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | g/m^2 | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | ml/m^2 | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | cm/s | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change in Echocardiography Parameters: Isovolumic Relaxation Time | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | ms | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity | A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | m/s | | Baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores | The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values for each domain, were included in the analysis for that domain. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | score on a scale | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened | The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened. | Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Number | | Percentage of participants | | 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV | The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases. | Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Number | | Percentage of participants | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | mL/min/1.73m^2 | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Serum Creatinine | Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement. | Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | µmol/L | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Albumin/Creatinine Ratio | Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement. | Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure | A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement. | Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht | A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement. | Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study. | Posted | | Least Squares Mean | Standard Error | Percent | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Arterial Stiffness Parameters: Heart Rate | A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement. | Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study. | Posted | | Least Squares Mean | Standard Error | bpm | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity | A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement. | Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study. | Posted | | Least Squares Mean | Standard Error | cm/s | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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| Secondary | Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP) | Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement. | Extension efficacy set: The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period. | Posted | | Least Squares Mean | Standard Error | mmHg | | baseline, 36 weeks | | | | ID | Title | Description |
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| OG000 | LCZ696 | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. | | OG001 | Valsartan | During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid. |
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