| Primary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI) | The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | L/min/m2 | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
| | | Title | Denominators | Categories |
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| 1 hour infusion (5 ng/kg/min) | | | Title | Measurements |
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| - OG000-0.03± 0.19
- OG0010.24± 0.14
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| | 2 hour infusion (15 ng/kg/min) | | |
| | 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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| 90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose. | ANCOVA | one-sided p-value and one-sided alpha=0.05 | 0.0595 | | Mean Difference (Final Values) | 0.27 | | | 2-Sided | 90 | -0.016 | 0.564 | | | | No | Superiority or Other | | | |
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| Primary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP) | The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in heart rate (HR) at each time point as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | beats per minute (bpm) | | At 1-hour, 2 hours and 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in systolic blood pressure (SBP) at each time point as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP) | The primary analysis of this study focused on the differences between the treatment groups in terms of LS mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in Least Square (LS) means (and associated confidence intervals) for change from Baseline in diastolic blood pressure(DBP) at each time point as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mL | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular End Diastolic Volume (LVEDV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mL | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular Ejection Fraction (LVEF) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | percentage | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Fractional Shortening (FS) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | percentage | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Stroke Volume (SV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mL/beat | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Systolic Pressure (PASP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Square (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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| Secondary | Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR) | The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Calculated Systemic Vascular Resistance (SVR) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors. | The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set. | Posted | | Least Squares Mean | Standard Error | dyn.s.cm-5 | | Baseline up through 3 hours post infusion initiation | | | | ID | Title | Description |
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| OG000 | Placebo | Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. | | OG001 | JNJ-39588146 | Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min. |
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