Heart Failure, Congestive
Conditions
Keywords
Heart failure, congestive, Nesiritide and, JNS004
Brief summary
The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in participants with acute (a quick and severe form of illness in its early stage) heart failure (when the heart inadequately pumps blood through the body) including acute exacerbation of chronic (lasting a long time) heart failure, administered intravenous (into a vein) bolus (a large amount) followed by intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle).
Detailed description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, unblinded), multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (study medication assigned by chance), stepwise, bolus plus intravenous infusion, fixed-flexible (arbitrary dose titration \[slow increase in drug dosage, guided by participant's responses\]) study. The study consists of 3 periods: Observation period (from the time of obtaining consent to the start of study treatment), Treatment period, and Follow-up period (from 24 hours after the initiation of study treatment \[discontinuation\] to 30 days after the initiation of study treatment). The participants will be randomly assigned to 1 of the following 3 treatment groups: 2+0.005 group, 1+0.01 group and 2+0.01 group. The treatment period consists of treatment with bolus injection (over 1 minute) followed by intravenous infusion (over 24 hours: Period 1 \[fixed-dose period\] of 3 hours and Period 2 \[flexible-dose period\] of 21 hours).The study will be conducted stepwise and hence, initially participants will be randomly assigned to 1 of the following 2 groups: 1+0.01 group and 2+0.005 group. Participants will receive nesiritide at an initial dose of 0.005 or 0.01 microgram per kilogram per minute (mcg/kg/min), and the dose escalation of 0.005 mcg/kg/min per dose will be conducted every 3 hours up to maximum of 0.03 mcg/kg/min in Period 2. Safety data of at least 5 participants will be assessed for each group, and after confirming the safety of 2 groups, the participants will be assigned to third group of nesiritide 2 microgram per kilogram (mcg/kg) +0.01 mcg/kg/min. Then participants will be followed up to a maximum of 30 days after the initiation of study treatment, in follow-up period. Participants will primarily be evaluated for the effect of nesiritide on hemodynamic parameters such as pulmonary capillary wedge pressure (PCWP), or if it is unmeasurable then it will be complemented with pulmonary arterial diastolic pressure (PADP). Participants' safety will also be monitored throughout the study.
Interventions
DRUGNesiritide (1+0.01)
Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 15.4 to 35.2 mcg/kg.
DRUGNesiritide (2+0.005)
Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 9.2 to 31.7 mcg/kg.
DRUGNesritide (2+0.01)
Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage will be increased by 0.005 mcg/kg/min every 3 hours. Total dosage to be administered will be 16.4 to 36.2 mcg/kg.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with acute heart failure (including acute exacerbation of chronic heart failure) requiring hospitalization whose placement of right-heart catheter (flexible, tube-like tool used to take fluids out or put fluids into the body) is judged to be possible and useful for treatment * Participants with findings of pulmonary (having to do with the lungs) congestion on a chest X-ray (an image of a site produced on photographic film by X-rays passing through the site) film taken within 12 hours before starting the treatment * Participants with 2 systolic blood pressure (SBP: refers to blood pressure \[pressure of the blood on the arteries and other blood vessel\] when the heart beats while pumping blood) values greater than or equal to 100 millimeters of mercury (mmHg) measured at an interval of at least 15 minutes in the hemodynamic (related to blood flow) assessment in observation period * In a hemodynamic assessment in observation period, participants with 2 pulmonary capillary wedge pressure (PCWP \[if it is not available, pulmonary arterial diastolic pressure {PADP}\]) values greater than or equal to 18 mmHg measured at an interval of at least 15 minutes and the second measurement value is within positive 20 percent (%) and negative 20% compared with the first 1
Exclusion criteria
* Participants with severe (very serious, life threatening) hepatic (to do with liver) impairment or renal (to do with kidney) impairment, cancer (abnormal tissue that grows and spreads in the body until it kills), or malignant (cancerous) tumor (a mass in a specific area) * Participants who are or may be pregnant or breast-feeding * Participants receiving non-invasive (puncture, opening or cutting of the skin) positive pressure ventilation (NIPPV) or scheduled to receive this during the study period * Participants who received treatment with another investigational product within 4 weeks before the initiation of investigational treatment or who were enrolled in a clinical study of nesiritide in the past * Participants who received prohibited concomitant medications within 3 hours before the initiation of investigational treatment or those who are receiving such a medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Baseline and 3 Hours | Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Orthopnea | Baseline, 1 and 24 hour | Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms |
| Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter. |
| Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter. |
| Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter. |
| Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter. |
| Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. |
| Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique. |
| Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33\*\[SBP-DBP\]) |
| Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area. |
| Number of Participants With Oxygen Therapy | Baseline,1 and 24 hour | Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy. |
| Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA). |
| Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80\*\[MBP-MRAP\]) and CO. |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80\*\[MPAP-PCWP\]) and CO. |
| Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline, 1 h and 24 h | Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum. |
| Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | 3, 6 and 24 hour | Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse |
| Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour | Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA) |
| Assessment of Dyspnea Using Respiratory Rate | Baseline, 1, 2, 3, 6, 9, 15 and 24 hour | Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute |
| Urinary Volume | Baseline, 3 and 24 hour | The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed. |
| Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR). |
Countries
Japan
Participant flow
Pre-assignment details
67 participants provided consent, out of these 61 participants were assigned to the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Nesiritide (1+ 0.01) Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg. | 19 |
| Nesiritide (2+0.005) Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg. | 20 |
| Nesiritide (2+0.01) Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg. | 17 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period I | Physician Decision | 0 | 0 | 1 |
| Period II | Treatment Discontinuation | 3 | 1 | 3 |
Baseline characteristics
| Characteristic | Nesiritide (1+ 0.01) | Nesiritide (2+0.005) | Nesiritide (2+0.01) | Total |
|---|---|---|---|---|
| Age, Continuous | 71.1 Years STANDARD_DEVIATION 14.1 | 67.5 Years STANDARD_DEVIATION 13.5 | 64.9 Years STANDARD_DEVIATION 11.6 | 67.9 Years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 10 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 21 | 16 / 20 | 17 / 19 |
| serious Total, serious adverse events | 3 / 21 | 3 / 20 | 4 / 19 |
Outcome results
Primary
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours
Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
Time frame: Baseline and 3 Hours
Population: The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Baseline | 27.7 Millimeters of Mercury (mmHg) | Standard Deviation 8.2 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Change at 3 hours | -6.7 Millimeters of Mercury (mmHg) | Standard Deviation 5.8 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Baseline | 24.8 Millimeters of Mercury (mmHg) | Standard Deviation 6.3 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Change at 3 hours | -5.4 Millimeters of Mercury (mmHg) | Standard Deviation 6.3 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Baseline | 29.7 Millimeters of Mercury (mmHg) | Standard Deviation 6.6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours | Change at 3 hours | -6.2 Millimeters of Mercury (mmHg) | Standard Deviation 6.8 |
Secondary
Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)
Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA)
Time frame: Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour
Population: The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Baseline (n=19,20,17) | 96.5 Percentage of SpO2 | Standard Deviation 2.9 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 1 hour (n=18,20,17) | 96.6 Percentage of SpO2 | Standard Deviation 2.2 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 2 hour (n=19,20,17) | 96.8 Percentage of SpO2 | Standard Deviation 2.3 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 3 hour (n=19,20,17) | 96.7 Percentage of SpO2 | Standard Deviation 2.7 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 6 hour (n=13,15,17) | 97.6 Percentage of SpO2 | Standard Deviation 1.8 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 9 hour (n=0,1,0) | NA Percentage of SpO2 | — |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 15 hour (n=2,1,0) | 94.5 Percentage of SpO2 | Standard Deviation 3.5 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 24 hour (n=14,19,15) | 97.1 Percentage of SpO2 | Standard Deviation 1.8 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 2 hour (n=19,20,17) | 96.8 Percentage of SpO2 | Standard Deviation 2.4 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 15 hour (n=2,1,0) | 99.0 Percentage of SpO2 | — |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 3 hour (n=19,20,17) | 96.9 Percentage of SpO2 | Standard Deviation 2.6 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 6 hour (n=13,15,17) | 97.3 Percentage of SpO2 | Standard Deviation 1.9 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 9 hour (n=0,1,0) | 100.0 Percentage of SpO2 | — |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Baseline (n=19,20,17) | 96.4 Percentage of SpO2 | Standard Deviation 2.3 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 1 hour (n=18,20,17) | 96.6 Percentage of SpO2 | Standard Deviation 2.2 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 24 hour (n=14,19,15) | 97.1 Percentage of SpO2 | Standard Deviation 1.8 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 2 hour (n=19,20,17) | 97.7 Percentage of SpO2 | Standard Deviation 1.4 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 1 hour (n=18,20,17) | 96.4 Percentage of SpO2 | Standard Deviation 5.2 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | Baseline (n=19,20,17) | 96.9 Percentage of SpO2 | Standard Deviation 2 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 3 hour (n=19,20,17) | 98.4 Percentage of SpO2 | Standard Deviation 0.9 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 15 hour (n=2,1,0) | NA Percentage of SpO2 | — |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 9 hour (n=0,1,0) | NA Percentage of SpO2 | — |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 6 hour (n=13,15,17) | 97.5 Percentage of SpO2 | Standard Deviation 1.5 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2) | At 24 hour (n=14,19,15) | 98.1 Percentage of SpO2 | Standard Deviation 1.8 |
Secondary
Assessment of Dyspnea Using Respiratory Rate
Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute
Time frame: Baseline, 1, 2, 3, 6, 9, 15 and 24 hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 2 hour (n= 19,20,17) | 23.2 Breaths Per Minute (BrPM) | Standard Deviation 7.7 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | Baseline (n= 19,20,17) | 24.7 Breaths Per Minute (BrPM) | Standard Deviation 7.8 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 3 hour (n= 19,20,17) | 22.7 Breaths Per Minute (BrPM) | Standard Deviation 7.1 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 24 hour (n= 14,18,17) | 19.4 Breaths Per Minute (BrPM) | Standard Deviation 3.9 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 1 hour (n= 18,20,17) | 24.0 Breaths Per Minute (BrPM) | Standard Deviation 8.3 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 6 hour (n= 13,15,17) | 21.2 Breaths Per Minute (BrPM) | Standard Deviation 3.7 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 15 hour (n=2,1,0) | 22.0 Breaths Per Minute (BrPM) | Standard Deviation 7.1 |
| Nesiritide (1+ 0.01) | Assessment of Dyspnea Using Respiratory Rate | At 9 hour (n= 0,1,0) | NA Breaths Per Minute (BrPM) | — |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 1 hour (n= 18,20,17) | 23.0 Breaths Per Minute (BrPM) | Standard Deviation 3.9 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 9 hour (n= 0,1,0) | 22.0 Breaths Per Minute (BrPM) | — |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | Baseline (n= 19,20,17) | 25.6 Breaths Per Minute (BrPM) | Standard Deviation 6.5 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 15 hour (n=2,1,0) | 33.0 Breaths Per Minute (BrPM) | — |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 24 hour (n= 14,18,17) | 20.8 Breaths Per Minute (BrPM) | Standard Deviation 5 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 2 hour (n= 19,20,17) | 22.1 Breaths Per Minute (BrPM) | Standard Deviation 4.1 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 3 hour (n= 19,20,17) | 22.9 Breaths Per Minute (BrPM) | Standard Deviation 5.1 |
| Nesiritide (2+0.005) | Assessment of Dyspnea Using Respiratory Rate | At 6 hour (n= 13,15,17) | 21.8 Breaths Per Minute (BrPM) | Standard Deviation 4.9 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 24 hour (n= 14,18,17) | 21.4 Breaths Per Minute (BrPM) | Standard Deviation 4.3 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | Baseline (n= 19,20,17) | 23.8 Breaths Per Minute (BrPM) | Standard Deviation 7.8 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 1 hour (n= 18,20,17) | 22.6 Breaths Per Minute (BrPM) | Standard Deviation 6.5 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 2 hour (n= 19,20,17) | 21.2 Breaths Per Minute (BrPM) | Standard Deviation 6.2 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 3 hour (n= 19,20,17) | 20.4 Breaths Per Minute (BrPM) | Standard Deviation 6.7 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 6 hour (n= 13,15,17) | 20.5 Breaths Per Minute (BrPM) | Standard Deviation 4.9 |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 9 hour (n= 0,1,0) | NA Breaths Per Minute (BrPM) | — |
| Nesiritide (2+0.01) | Assessment of Dyspnea Using Respiratory Rate | At 15 hour (n=2,1,0) | NA Breaths Per Minute (BrPM) | — |
Secondary
Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.143 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.758 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 0.239 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.357 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -0.307 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.732 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -0.175 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.672 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.199 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.442 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -0.212 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.733 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -0.011 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.613 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | -0.318 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.518 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -0.153 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.556 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 0.226 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.555 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n= 14,19,15) | 0.054 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.617 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 2.712 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.826 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.166 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.673 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -0.274 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.331 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Liter per minute per meter^2 (l/min/m^2) | — |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 0.185 Liter per minute per meter^2 (l/min/m^2) | — |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 2.356 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.527 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.305 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.395 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 0.443 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.451 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 0.445 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.404 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.293 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.477 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.165 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.535 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | 0.042 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.425 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | 0.092 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.388 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | 0.055 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.431 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | 0.061 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.329 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -0.127 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.368 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | -0.201 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.37 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 0.186 Liter per minute per meter^2 (l/min/m^2) | — |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n= 14,19,15) | -0.199 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.507 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.216 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.459 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Liter per minute per meter^2 (l/min/m^2) | — |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | 0.103 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.622 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.439 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.603 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 0.695 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.443 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Liter per minute per meter^2 (l/min/m^2) | — |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 0.861 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.783 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 2.382 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.549 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | 0.185 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.78 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | 0.029 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.56 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.232 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.54 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | 0.131 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.324 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | 0.158 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.492 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n= 14,19,15) | 0.148 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.754 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | 0.153 Liter per minute per meter^2 (l/min/m^2) | Standard Deviation 0.572 |
Secondary
Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -0.3356 Liter per minute | Standard Deviation 1.2717 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.2795 Liter per minute | Standard Deviation 1.1145 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -0.4500 Liter per minute | Standard Deviation 0.5657 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -0.2742 Liter per minute | Standard Deviation 0.9836 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.3026 Liter per minute | Standard Deviation 1.3596 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | -0.5453 Liter per minute | Standard Deviation 0.8935 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | 0.0095 Liter per minute | Standard Deviation 1.0695 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -0.3105 Liter per minute | Standard Deviation 1.177 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Liter per minute | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.2947 Liter per minute | Standard Deviation 0.7227 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 0.3721 Liter per minute | Standard Deviation 0.6143 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -0.1246 Liter per minute | Standard Deviation 1.1352 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -0.5706 Liter per minute | Standard Deviation 1.4351 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 0.3668 Liter per minute | Standard Deviation 0.9398 |
| Nesiritide (1+ 0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 4.4026 Liter per minute | Standard Deviation 1.4463 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -0.1994 Liter per minute | Standard Deviation 0.6581 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 0.3500 Liter per minute | — |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 3.9768 Liter per minute | Standard Deviation 1.2767 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.5686 Liter per minute | Standard Deviation 0.7616 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 0.8102 Liter per minute | Standard Deviation 0.9328 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 0.7838 Liter per minute | Standard Deviation 0.7643 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.5947 Liter per minute | Standard Deviation 1.1077 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.3497 Liter per minute | Standard Deviation 1.0715 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | 0.0292 Liter per minute | Standard Deviation 0.6977 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | 0.1597 Liter per minute | Standard Deviation 0.7112 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | 0.1435 Liter per minute | Standard Deviation 0.765 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | 0.1472 Liter per minute | Standard Deviation 0.6739 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | -0.3177 Liter per minute | Standard Deviation 0.6534 |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 0.3000 Liter per minute | — |
| Nesiritide (2+0.005) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -0.3108 Liter per minute | Standard Deviation 0.8702 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | 0.1912 Liter per minute | Standard Deviation 0.5167 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | 1.1382 Liter per minute | Standard Deviation 0.6744 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Liter per minute | — |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | 1.4147 Liter per minute | Standard Deviation 1.2028 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | 0.2912 Liter per minute | Standard Deviation 0.9378 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Liter per minute | — |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 4.0971 Liter per minute | Standard Deviation 1.4259 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | 0.2676 Liter per minute | Standard Deviation 0.9761 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=16,19,17) | 0.2853 Liter per minute | Standard Deviation 1.207 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | 0.3029 Liter per minute | Standard Deviation 0.9547 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | 0.3500 Liter per minute | Standard Deviation 0.7163 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | 0.1735 Liter per minute | Standard Deviation 1.0341 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -0.0265 Liter per minute | Standard Deviation 0.817 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 0.7206 Liter per minute | Standard Deviation 1.0939 |
| Nesiritide (2+0.01) | Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -0.3200 Liter per minute | Standard Deviation 1.1894 |
Secondary
Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour
The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33\*\[SBP-DBP\])
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 9 hour (n=19,20,17) | -17.689 Millimeters of mercury | Standard Deviation 17.866 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -8.497 Millimeters of mercury | Standard Deviation 14.396 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -6.053 Millimeters of mercury | Standard Deviation 6.452 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Baseline (n=19,20,17) | 109.397 Millimeters of mercury | Standard Deviation 15.868 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 3 hour (n=19,20,17) | -8.773 Millimeters of mercury | Standard Deviation 14.66 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 18 hour (n=19,20,17) | -16.040 Millimeters of mercury | Standard Deviation 21.176 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 6 hour (n=19,20,17) | -15.167 Millimeters of mercury | Standard Deviation 17.875 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 4 hour (n=19,20,17) | -10.310 Millimeters of mercury | Standard Deviation 12.873 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1 hour (n=19,20,17) | -6.900 Millimeters of mercury | Standard Deviation 8.89 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 5 hour (n=18,20,17) | -12.541 Millimeters of mercury | Standard Deviation 11.645 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 24 hour (n= 19,20,16) | -16.590 Millimeters of mercury | Standard Deviation 19.882 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 15 hour (n=19,20,17) | -16.050 Millimeters of mercury | Standard Deviation 18.244 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -7.412 Millimeters of mercury | Standard Deviation 12.835 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 21 hour (n=19,20,17) | -16.933 Millimeters of mercury | Standard Deviation 18.362 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 12 hour (n=19,20,17) | -16.107 Millimeters of mercury | Standard Deviation 19.174 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2 hour (n=19,20,17) | -10.032 Millimeters of mercury | Standard Deviation 11.474 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -4.626 Millimeters of mercury | Standard Deviation 7.316 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 6 hour (n=19,20,17) | -12.241 Millimeters of mercury | Standard Deviation 16.07 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Baseline (n=19,20,17) | 106.169 Millimeters of mercury | Standard Deviation 20.438 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -9.167 Millimeters of mercury | Standard Deviation 8.975 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -9.930 Millimeters of mercury | Standard Deviation 8.124 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.863 Millimeters of mercury | Standard Deviation 8.599 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -10.181 Millimeters of mercury | Standard Deviation 9.339 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2 hour (n=19,20,17) | -11.149 Millimeters of mercury | Standard Deviation 10.411 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -12.516 Millimeters of mercury | Standard Deviation 9.011 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 3 hour (n=19,20,17) | -11.666 Millimeters of mercury | Standard Deviation 9.572 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 4 hour (n=19,20,17) | -10.858 Millimeters of mercury | Standard Deviation 10.196 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 5 hour (n=18,20,17) | -9.301 Millimeters of mercury | Standard Deviation 10.935 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 9 hour (n=19,20,17) | -9.287 Millimeters of mercury | Standard Deviation 17.532 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 12 hour (n=19,20,17) | -13.113 Millimeters of mercury | Standard Deviation 13.733 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 15 hour (n=19,20,17) | -11.584 Millimeters of mercury | Standard Deviation 15.233 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 18 hour (n=19,20,17) | -16.331 Millimeters of mercury | Standard Deviation 16.193 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 21 hour (n=19,20,17) | -14.267 Millimeters of mercury | Standard Deviation 16.993 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 24 hour (n= 19,20,16) | -12.162 Millimeters of mercury | Standard Deviation 17.803 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -7.098 Millimeters of mercury | Standard Deviation 14.093 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 9 hour (n=19,20,17) | -14.619 Millimeters of mercury | Standard Deviation 14.311 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1.5 hour (n=19,20,17) | 4.969 Millimeters of mercury | Standard Deviation 11.997 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 24 hour (n= 19,20,16) | -11.135 Millimeters of mercury | Standard Deviation 12.593 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 12 hour (n=19,20,17) | -16.103 Millimeters of mercury | Standard Deviation 15.392 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.685 Millimeters of mercury | Standard Deviation 12.821 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 21 hour (n=19,20,17) | -18.684 Millimeters of mercury | Standard Deviation 20.086 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 15 hour (n=19,20,17) | -15.590 Millimeters of mercury | Standard Deviation 13.885 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -9.450 Millimeters of mercury | Standard Deviation 10.543 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Baseline (n=19,20,17) | 105.006 Millimeters of mercury | Standard Deviation 17.781 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 4 hour (n=19,20,17) | -5.681 Millimeters of mercury | Standard Deviation 11.438 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 18 hour (n=19,20,17) | -15.962 Millimeters of mercury | Standard Deviation 16.456 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 5 hour (n=18,20,17) | -8.254 Millimeters of mercury | Standard Deviation 11.07 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 3 hour (n=19,20,17) | -9.517 Millimeters of mercury | Standard Deviation 11.114 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -6.890 Millimeters of mercury | Standard Deviation 10.768 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 6 hour (n=19,20,17) | -9.281 Millimeters of mercury | Standard Deviation 12.96 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour | Change at 2 hour (n=19,20,17) | -6.669 Millimeters of mercury | Standard Deviation 9.468 |
Secondary
Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -8.1 Millimeters of mercury | Standard Deviation 10.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -5.4 Millimeters of mercury | Standard Deviation 7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -3.2 Millimeters of mercury | Standard Deviation 5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -5.0 Millimeters of mercury | Standard Deviation 5.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -7.7 Millimeters of mercury | Standard Deviation 8.4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -5.3 Millimeters of mercury | Standard Deviation 7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -4.8 Millimeters of mercury | Standard Deviation 7.4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -7.5 Millimeters of mercury | Standard Deviation 8.7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 3.5 Millimeters of mercury | Standard Deviation 7.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -7.0 Millimeters of mercury | Standard Deviation 7.2 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -8.3 Millimeters of mercury | Standard Deviation 8.3 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 38.2 Millimeters of mercury | Standard Deviation 10.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -6.5 Millimeters of mercury | Standard Deviation 7.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -2.3 Millimeters of mercury | Standard Deviation 3.8 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -8.6 Millimeters of mercury | Standard Deviation 9 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -6.0 Millimeters of mercury | Standard Deviation 7.2 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -7.8 Millimeters of mercury | Standard Deviation 6.7 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 4.5 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 34.5 Millimeters of mercury | Standard Deviation 8.5 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -7.0 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -6.7 Millimeters of mercury | Standard Deviation 7.4 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -6.7 Millimeters of mercury | Standard Deviation 6.6 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -5.7 Millimeters of mercury | Standard Deviation 7.1 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -4.9 Millimeters of mercury | Standard Deviation 7.8 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -5.6 Millimeters of mercury | Standard Deviation 8.5 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -5.0 Millimeters of mercury | Standard Deviation 7.1 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -6.3 Millimeters of mercury | Standard Deviation 6.8 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 12.5 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -7.6 Millimeters of mercury | Standard Deviation 7.2 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 42.6 Millimeters of mercury | Standard Deviation 7.8 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -5.5 Millimeters of mercury | Standard Deviation 4.4 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -5.9 Millimeters of mercury | Standard Deviation 6.1 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -11.0 Millimeters of mercury | Standard Deviation 6.1 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -7.1 Millimeters of mercury | Standard Deviation 6.1 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -11.3 Millimeters of mercury | Standard Deviation 7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -7.8 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.8 Millimeters of mercury | Standard Deviation 5.4 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -7.8 Millimeters of mercury | Standard Deviation 4.7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -6.4 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -4.9 Millimeters of mercury | Standard Deviation 4.6 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -9.5 Millimeters of mercury | Standard Deviation 7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -6.7 Millimeters of mercury | Standard Deviation 6.5 |
Secondary
Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour
The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Baseline (n=19,18,16) | 14.5 Millimeters of mercury | Standard Deviation 9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -3.8 Millimeters of mercury | Standard Deviation 6.3 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 4 hour (n=19,17,16) | -4.9 Millimeters of mercury | Standard Deviation 4.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -1.9 Millimeters of mercury | Standard Deviation 3.4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 24 hour (n=14,17,14) | -5.2 Millimeters of mercury | Standard Deviation 4.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2.5 hour(n=19,18,16) | -4.2 Millimeters of mercury | Standard Deviation 4.7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -2.6 Millimeters of mercury | Standard Deviation 4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 12 hour (n=17,17,16) | -5.9 Millimeters of mercury | Standard Deviation 6.7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1 hour (n=19,18,16) | -3.6 Millimeters of mercury | Standard Deviation 3.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 5 hour (n=18,17,16) | -5.0 Millimeters of mercury | Standard Deviation 5.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2 hour (n=19,18,16) | -4.3 Millimeters of mercury | Standard Deviation 6.2 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 1.0 Millimeters of mercury | Standard Deviation 2.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 3 hour (n=19,18,16) | -4.4 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 6 hour (n=18,17,16) | -5.1 Millimeters of mercury | Standard Deviation 4.8 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2 hour (n=19,18,16) | -2.8 Millimeters of mercury | Standard Deviation 4.3 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1 hour (n=19,18,16) | -2.7 Millimeters of mercury | Standard Deviation 3.4 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2.5 hour(n=19,18,16) | -2.5 Millimeters of mercury | Standard Deviation 4.1 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 3 hour (n=19,18,16) | -2.5 Millimeters of mercury | Standard Deviation 3.7 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 4 hour (n=19,17,16) | -2.0 Millimeters of mercury | Standard Deviation 4.2 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 5 hour (n=18,17,16) | -3.0 Millimeters of mercury | Standard Deviation 4.6 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 12 hour (n=17,17,16) | -3.4 Millimeters of mercury | Standard Deviation 3.2 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Baseline (n=19,18,16) | 10.3 Millimeters of mercury | Standard Deviation 6.8 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -2.5 Millimeters of mercury | Standard Deviation 3 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -3.1 Millimeters of mercury | Standard Deviation 3.2 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -3.4 Millimeters of mercury | Standard Deviation 4.5 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 6 hour (n=18,17,16) | -3.3 Millimeters of mercury | Standard Deviation 3.7 |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -3.5 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 24 hour (n=14,17,14) | -4.5 Millimeters of mercury | Standard Deviation 4.7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -2.6 Millimeters of mercury | Standard Deviation 2.4 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 3 hour (n=19,18,16) | -2.9 Millimeters of mercury | Standard Deviation 4.7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Baseline (n=19,18,16) | 13.1 Millimeters of mercury | Standard Deviation 6.2 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 5 hour (n=18,17,16) | -2.9 Millimeters of mercury | Standard Deviation 7.1 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 12 hour (n=17,17,16) | -4.3 Millimeters of mercury | Standard Deviation 4.2 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1 hour (n=19,18,16) | 3.6 Millimeters of mercury | Standard Deviation 3.4 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 6 hour (n=18,17,16) | -3.1 Millimeters of mercury | Standard Deviation 6.9 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 4 hour (n=19,17,16) | -2.9 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2.5 hour(n=19,18,16) | -3.2 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 24 hour (n=14,17,14) | -5.0 Millimeters of mercury | Standard Deviation 5.3 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -3.8 Millimeters of mercury | Standard Deviation 3.3 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -3.4 Millimeters of mercury | Standard Deviation 2.7 |
| Nesiritide (2+0.01) | Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour | Change at 2 hour (n=19,18,16) | -3.4 Millimeters of mercury | Standard Deviation 3.8 |
Secondary
Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -6.3 Millimeters of mercury | Standard Deviation 7.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -4.0 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 3.5 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -4.7 Millimeters of mercury | Standard Deviation 6.7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -3.2 Millimeters of mercury | Standard Deviation 6.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -6.7 Millimeters of mercury | Standard Deviation 6.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 26.5 Millimeters of mercury | Standard Deviation 8.4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 (n=19,20,17) | -3.5 Millimeters of mercury | Standard Deviation 6.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -5.7 Millimeters of mercury | Standard Deviation 5.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -6.8 Millimeters of mercury | Standard Deviation 8.3 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -1.6 Millimeters of mercury | Standard Deviation 3.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -6.7 Millimeters of mercury | Standard Deviation 7.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -2.8 Millimeters of mercury | Standard Deviation 4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -4.6 Millimeters of mercury | Standard Deviation 6.4 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 14.0 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -4.4 Millimeters of mercury | Standard Deviation 5.6 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 24.2 Millimeters of mercury | Standard Deviation 7.4 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -6.1 Millimeters of mercury | Standard Deviation 4.6 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -6.9 Millimeters of mercury | Standard Deviation 5.6 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -5.7 Millimeters of mercury | Standard Deviation 6.1 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -5.6 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -5.4 Millimeters of mercury | Standard Deviation 5.3 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 (n=19,20,17) | -3.6 Millimeters of mercury | Standard Deviation 4.8 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -3.6 Millimeters of mercury | Standard Deviation 5.3 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -4.5 Millimeters of mercury | Standard Deviation 5.4 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -4.1 Millimeters of mercury | Standard Deviation 5.6 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -5.6 Millimeters of mercury | Standard Deviation 5.2 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 3.5 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -6.0 Millimeters of mercury | Standard Deviation 6.4 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -8.0 Millimeters of mercury | Standard Deviation 6.4 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -8.0 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -4.6 Millimeters of mercury | Standard Deviation 3.3 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -6.9 Millimeters of mercury | Standard Deviation 4.3 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 30.1 Millimeters of mercury | Standard Deviation 8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -5.9 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -5.6 Millimeters of mercury | Standard Deviation 5.3 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -8.9 Millimeters of mercury | Standard Deviation 7.6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 (n=19,20,17) | -6.2 Millimeters of mercury | Standard Deviation 5.9 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.0 Millimeters of mercury | Standard Deviation 4.4 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -6.5 Millimeters of mercury | Standard Deviation 5.2 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -6.5 Millimeters of mercury | Standard Deviation 5.6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -6.6 Millimeters of mercury | Standard Deviation 4.3 |
Secondary
Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -7.2 Millimeters of mercury | Standard Deviation 8.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -11.3 Millimeters of mercury | Standard Deviation 12.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.0 Millimeters of mercury | Standard Deviation 8.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -3.6 Millimeters of mercury | Standard Deviation 6.2 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 6.0 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -7.0 Millimeters of mercury | Standard Deviation 9.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -5.3 Millimeters of mercury | Standard Deviation 7.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -9.4 Millimeters of mercury | Standard Deviation 10.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -9.3 Millimeters of mercury | Standard Deviation 10.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 55.9 Millimeters of mercury | Standard Deviation 16.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -10.2 Millimeters of mercury | Standard Deviation 12.2 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -9.9 Millimeters of mercury | Standard Deviation 12.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -6.2 Millimeters of mercury | Standard Deviation 9.1 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -10.0 Millimeters of mercury | Standard Deviation 12.6 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -8.7 Millimeters of mercury | Standard Deviation 9.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -6.1 Millimeters of mercury | Standard Deviation 9.7 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 13.0 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -8.2 Millimeters of mercury | Standard Deviation 7.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -9.1 Millimeters of mercury | Standard Deviation 10.4 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -6.8 Millimeters of mercury | Standard Deviation 9.1 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -10.4 Millimeters of mercury | Standard Deviation 11.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -6.8 Millimeters of mercury | Standard Deviation 9.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -7.6 Millimeters of mercury | Standard Deviation 8 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -8.7 Millimeters of mercury | Standard Deviation 9.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -5.9 Millimeters of mercury | Standard Deviation 7.4 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | 6.0 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -6.1 Millimeters of mercury | Standard Deviation 8.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -5.7 Millimeters of mercury | Standard Deviation 9.2 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 51.3 Millimeters of mercury | Standard Deviation 11.1 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=14,19,15) | -12.2 Millimeters of mercury | Standard Deviation 7.6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=19,20,17) | -8.8 Millimeters of mercury | Standard Deviation 6.6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=19,20,17) | -7.0 Millimeters of mercury | Standard Deviation 6.3 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=19,20,17) | 59.8 Millimeters of mercury | Standard Deviation 12 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=19,19,17) | -4.2 Millimeters of mercury | Standard Deviation 5.2 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=19,20,17) | -5.5 Millimeters of mercury | Standard Deviation 4.8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=19,20,17) | -7.4 Millimeters of mercury | Standard Deviation 5.7 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=19,20,17) | -6.6 Millimeters of mercury | Standard Deviation 6.9 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=19,20,17) | -6.4 Millimeters of mercury | Standard Deviation 7.8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=19,19,17) | -7.5 Millimeters of mercury | Standard Deviation 6.9 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=18,19,17) | -8.2 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=18,19,17) | -10.1 Millimeters of mercury | Standard Deviation 7.7 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=17,19,17) | -12.7 Millimeters of mercury | Standard Deviation 7.7 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA Millimeters of mercury | — |
Secondary
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 27.0 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | -8.6 Millimeters of mercury | Standard Deviation 2.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | -5.1 Millimeters of mercury | Standard Deviation 3.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -3.5 Millimeters of mercury | Standard Deviation 3.7 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | -7.9 Millimeters of mercury | Standard Deviation 3.8 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | -5.6 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -5.1 Millimeters of mercury | Standard Deviation 3.4 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | -6.5 Millimeters of mercury | Standard Deviation 4.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | -9.9 Millimeters of mercury | Standard Deviation 3.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | -9.7 Millimeters of mercury | Standard Deviation 6.6 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | -5.6 Millimeters of mercury | Standard Deviation 4.5 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | -4.5 Millimeters of mercury | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | -9.5 Millimeters of mercury | Standard Deviation 3 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | -5.5 Millimeters of mercury | Standard Deviation 3.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 24.3 Millimeters of mercury | Standard Deviation 5.1 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | -7.8 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -5.5 Millimeters of mercury | Standard Deviation 3.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -7.9 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | -7.6 Millimeters of mercury | Standard Deviation 5.3 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | -6.5 Millimeters of mercury | Standard Deviation 4.7 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | -6.3 Millimeters of mercury | Standard Deviation 5.1 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | -5.0 Millimeters of mercury | Standard Deviation 5.7 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | -4.9 Millimeters of mercury | Standard Deviation 6.2 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | -4.9 Millimeters of mercury | Standard Deviation 6.2 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | -5.8 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | -5.6 Millimeters of mercury | Standard Deviation 4.9 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 12.0 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | -1.0 Millimeters of mercury | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | -7.2 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | -10.5 Millimeters of mercury | Standard Deviation 3.9 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | -8.0 Millimeters of mercury | Standard Deviation 5 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | -8.5 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | -11.2 Millimeters of mercury | Standard Deviation 5.9 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -7.5 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 30.2 Millimeters of mercury | Standard Deviation 7 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA Millimeters of mercury | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | -7.9 Millimeters of mercury | Standard Deviation 6.4 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -5.1 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | -7.9 Millimeters of mercury | Standard Deviation 5.5 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | -7.6 Millimeters of mercury | Standard Deviation 6 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | -11.8 Millimeters of mercury | Standard Deviation 6.5 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | -7.5 Millimeters of mercury | Standard Deviation 5.8 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | 9.0 Millimeters of mercury | Standard Deviation 6.2 |
Secondary
Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80\*\[MPAP-PCWP\]) and CO.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | 11.083 dyne*second/centimeter^5 | Standard Deviation 69.935 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -12.954 dyne*second/centimeter^5 | Standard Deviation 70.125 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | 50.780 dyne*second/centimeter^5 | Standard Deviation 117.927 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | 32.991 dyne*second/centimeter^5 | Standard Deviation 59.277 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -19.361 dyne*second/centimeter^5 | Standard Deviation 79.932 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | 30.161 dyne*second/centimeter^5 | Standard Deviation 73.755 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | 6.691 dyne*second/centimeter^5 | Standard Deviation 88.625 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | 42.717 dyne*second/centimeter^5 | Standard Deviation 116.928 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | 12.217 dyne*second/centimeter^5 | Standard Deviation 103.059 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | -0.991 dyne*second/centimeter^5 | Standard Deviation 93.305 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | 32.656 dyne*second/centimeter^5 | Standard Deviation 76.762 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 215.736 dyne*second/centimeter^5 | Standard Deviation 124.776 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | 19.161 dyne*second/centimeter^5 | Standard Deviation 57.701 |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | 46.681 dyne*second/centimeter^5 | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA dyne*second/centimeter^5 | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 2.017 dyne*second/centimeter^5 | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 208.714 dyne*second/centimeter^5 | Standard Deviation 166.213 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -40.647 dyne*second/centimeter^5 | Standard Deviation 97.78 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -23.263 dyne*second/centimeter^5 | Standard Deviation 141.171 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | 1.964 dyne*second/centimeter^5 | Standard Deviation 110.283 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | -2.975 dyne*second/centimeter^5 | Standard Deviation 93.034 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | 23.400 dyne*second/centimeter^5 | Standard Deviation 116.715 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | 11.609 dyne*second/centimeter^5 | Standard Deviation 106.732 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | -2.667 dyne*second/centimeter^5 | Standard Deviation 122.33 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | 3.797 dyne*second/centimeter^5 | Standard Deviation 128.528 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | -10.958 dyne*second/centimeter^5 | Standard Deviation 87.255 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | 10.104 dyne*second/centimeter^5 | Standard Deviation 94.079 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | 20.625 dyne*second/centimeter^5 | Standard Deviation 109.345 |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | 116.667 dyne*second/centimeter^5 | — |
| Nesiritide (2+0.005) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | -29.072 dyne*second/centimeter^5 | Standard Deviation 133.105 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=14,18,12) | -2.991 dyne*second/centimeter^5 | Standard Deviation 104.337 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=1,1,0) | NA dyne*second/centimeter^5 | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=12,17,12) | -4.627 dyne*second/centimeter^5 | Standard Deviation 107.473 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=14,18,12) | -34.079 dyne*second/centimeter^5 | Standard Deviation 109.876 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=14,18,12) | -44.337 dyne*second/centimeter^5 | Standard Deviation 116.971 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA dyne*second/centimeter^5 | — |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=14,18,13) | -34.144 dyne*second/centimeter^5 | Standard Deviation 100.492 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=14,18,14) | 239.383 dyne*second/centimeter^5 | Standard Deviation 122.453 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=10,17,12) | -18.302 dyne*second/centimeter^5 | Standard Deviation 132.041 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=14,18,12) | 11.381 dyne*second/centimeter^5 | Standard Deviation 109.961 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=14,17,13) | -12.482 dyne*second/centimeter^5 | Standard Deviation 86.016 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=14,17,12) | -30.437 dyne*second/centimeter^5 | Standard Deviation 89.235 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=14,18,12) | 1.610 dyne*second/centimeter^5 | Standard Deviation 107.365 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=9,17,10) | -37.891 dyne*second/centimeter^5 | Standard Deviation 137.587 |
| Nesiritide (2+0.01) | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=12,17,12) | -21.678 dyne*second/centimeter^5 | Standard Deviation 97.09 |
Secondary
Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA).
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | 0.320 milliliter per meter^2 | Standard Deviation 8.458 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 3.196 milliliter per meter^2 | Standard Deviation 7.954 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -3.357 milliliter per meter^2 | Standard Deviation 0.593 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 0.525 milliliter per meter^2 | Standard Deviation 9.552 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour n=17,19,17) | 0.394 milliliter per meter^2 | Standard Deviation 7.126 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 4.116 milliliter per meter^2 | Standard Deviation 5.692 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 1.097 milliliter per meter^2 | Standard Deviation 5.952 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 2.751 milliliter per meter^2 | Standard Deviation 6.96 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | 1.690 milliliter per meter^2 | Standard Deviation 9.763 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | 1.100 milliliter per meter^2 | Standard Deviation 8.143 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 3.904 milliliter per meter^2 | Standard Deviation 5.927 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,18,17) | 2.888 milliliter per meter^2 | Standard Deviation 5.948 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA milliliter per meter^2 | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 2.822 milliliter per meter^2 | Standard Deviation 7.127 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 29.683 milliliter per meter^2 | Standard Deviation 11.141 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 4.657 milliliter per meter^2 | — |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 28.655 milliliter per meter^2 | Standard Deviation 9.81 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,18,17) | 1.853 milliliter per meter^2 | Standard Deviation 4.525 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 3.775 milliliter per meter^2 | Standard Deviation 6.143 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 4.892 milliliter per meter^2 | Standard Deviation 4.766 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 3.900 milliliter per meter^2 | Standard Deviation 5.161 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 3.526 milliliter per meter^2 | Standard Deviation 7.903 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour n=17,19,17) | 1.501 milliliter per meter^2 | Standard Deviation 6.587 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 1.781 milliliter per meter^2 | Standard Deviation 5.369 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 1.494 milliliter per meter^2 | Standard Deviation 5.568 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 2.427 milliliter per meter^2 | Standard Deviation 4.53 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | 1.421 milliliter per meter^2 | Standard Deviation 7.082 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | -0.912 milliliter per meter^2 | Standard Deviation 6.992 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -0.592 milliliter per meter^2 | — |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | -0.808 milliliter per meter^2 | Standard Deviation 7.217 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 4.948 milliliter per meter^2 | Standard Deviation 5.142 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA milliliter per meter^2 | — |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | 3.319 milliliter per meter^2 | Standard Deviation 6.079 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 8.007 milliliter per meter^2 | Standard Deviation 4.936 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 2.091 milliliter per meter^2 | Standard Deviation 5.535 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA milliliter per meter^2 | — |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 9.191 milliliter per meter^2 | Standard Deviation 8.552 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 24.483 milliliter per meter^2 | Standard Deviation 6.016 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | 5.610 milliliter per meter^2 | Standard Deviation 8.298 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour n=17,19,17) | 3.052 milliliter per meter^2 | Standard Deviation 5.474 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,18,17) | 2.584 milliliter per meter^2 | Standard Deviation 5.2 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 3.142 milliliter per meter^2 | Standard Deviation 3.461 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 3.760 milliliter per meter^2 | Standard Deviation 5.21 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | 0.590 milliliter per meter^2 | Standard Deviation 6.884 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 4.146 milliliter per meter^2 | Standard Deviation 6.125 |
Secondary
Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR).
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | 1.254 milliliter (ml) | Standard Deviation 13.051 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 48.368 milliliter (ml) | Standard Deviation 18.272 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,19,17) | 4.122 milliliter (ml) | Standard Deviation 9.604 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 6.348 milliliter (ml) | Standard Deviation 8.94 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 6.295 milliliter (ml) | Standard Deviation 9.587 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 4.666 milliliter (ml) | Standard Deviation 11.659 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 6.003 milliliter (ml) | Standard Deviation 14.727 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=17,19,17) | 0.133 milliliter (ml) | Standard Deviation 12.357 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 4.744 milliliter (ml) | Standard Deviation 12.37 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 1.477 milliliter (ml) | Standard Deviation 10.205 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 0.909 milliliter (ml) | Standard Deviation 16.362 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | -0.391 milliliter (ml) | Standard Deviation 15.734 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA milliliter (ml) | — |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -5.022 milliliter (ml) | Standard Deviation 1.839 |
| Nesiritide (1+ 0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | 2.333 milliliter (ml) | Standard Deviation 16.239 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | -1.357 milliliter (ml) | Standard Deviation 12.043 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 2.865 milliliter (ml) | Standard Deviation 8.973 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 49.126 milliliter (ml) | Standard Deviation 22.03 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=17,19,17) | 1.768 milliliter (ml) | Standard Deviation 11.073 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | 2.685 milliliter (ml) | Standard Deviation 13.448 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,19,17) | 3.305 milliliter (ml) | Standard Deviation 7.556 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | -1.421 milliliter (ml) | Standard Deviation 14.266 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 2.888 milliliter (ml) | Standard Deviation 9.53 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 6.887 milliliter (ml) | Standard Deviation 11.497 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 6.877 milliliter (ml) | Standard Deviation 15.55 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | -0.955 milliliter (ml) | — |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 8.442 milliliter (ml) | Standard Deviation 8.368 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 4.339 milliliter (ml) | Standard Deviation 8.641 |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | 8.792 milliliter (ml) | — |
| Nesiritide (2+0.005) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 7.722 milliliter (ml) | Standard Deviation 12.452 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 5 hour (n=16,18,17) | 6.802 milliliter (ml) | Standard Deviation 9.925 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 9 hour (n=0,1,0) | NA milliliter (ml) | — |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2 hour (n=17,19,17) | 6.119 milliliter (ml) | Standard Deviation 8.27 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 2.5 hour (n=17,19,17) | 5.490 milliliter (ml) | Standard Deviation 9.857 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 12 hour (n=15,18,17) | 9.123 milliliter (ml) | Standard Deviation 12.779 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 3 hour (n=17,19,17) | 2.909 milliliter (ml) | Standard Deviation 8.238 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 4 hour (n=17,18,17) | 5.053 milliliter (ml) | Standard Deviation 5.633 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1.5 hour (n=17,19,17) | 8.293 milliliter (ml) | Standard Deviation 9.497 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 15 hour (n=2,1,0) | NA milliliter (ml) | — |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Baseline (n=17,19,17) | 41.545 milliliter (ml) | Standard Deviation 12.29 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.25 hour (n=17,19,17) | 3.517 milliliter (ml) | Standard Deviation 8.589 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 6 hour (n=16,18,17) | 5.544 milliliter (ml) | Standard Deviation 9.81 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 0.5 hour (n=17,19,17) | 15.121 milliliter (ml) | Standard Deviation 13.429 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 24 hour (n=13,18,15) | 0.448 milliliter (ml) | Standard Deviation 11.288 |
| Nesiritide (2+0.01) | Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour | Change at 1 hour (n=17,19,17) | 13.039 milliliter (ml) | Standard Deviation 7.426 |
Secondary
Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour
The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80\*\[MBP-MRAP\]) and CO.
Time frame: Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 12 hour (n=16,17,16) | 157.757 dyne*second per centimeter^5 | Standard Deviation 743.728 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 4 hour (n=19,17,16) | -18.367 dyne*second per centimeter^5 | Standard Deviation 467.058 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2 hour (n=19,18,16) | -121.127 dyne*second per centimeter^5 | Standard Deviation 652.72 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -229.968 dyne*second per centimeter^5 | Standard Deviation 250.083 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 3 hour (n=19,18,16) | -81.183 dyne*second per centimeter^5 | Standard Deviation 487.205 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2.5 hour (n=19,18,16) | 49.262 dyne*second per centimeter^5 | Standard Deviation 797.66 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Baseline (n=19,18,16) | 1935.318 dyne*second per centimeter^5 | Standard Deviation 687.715 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -261.453 dyne*second per centimeter^5 | Standard Deviation 301.208 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 6 hour (n=18,17,16) | 0.026 dyne*second per centimeter^5 | Standard Deviation 562.942 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1 hour (n=19,18,16) | -265.611 dyne*second per centimeter^5 | Standard Deviation 419.843 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 24 hour (n=14,17,14) | -88.612 dyne*second per centimeter^5 | Standard Deviation 390.796 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 5 hour (n=18,17,16) | 40.462 dyne*second per centimeter^5 | Standard Deviation 592.227 |
| Nesiritide (1+ 0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -170.120 dyne*second per centimeter^5 | Standard Deviation 551.743 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2.5 hour (n=19,18,16) | -292.112 dyne*second per centimeter^5 | Standard Deviation 422.397 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Baseline (n=19,18,16) | 2170.633 dyne*second per centimeter^5 | Standard Deviation 896.353 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -366.981 dyne*second per centimeter^5 | Standard Deviation 340.678 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -453.601 dyne*second per centimeter^5 | Standard Deviation 505.637 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1 hour (n=19,18,16) | -456.113 dyne*second per centimeter^5 | Standard Deviation 496.625 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -328.746 dyne*second per centimeter^5 | Standard Deviation 299.522 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2 hour (n=19,18,16) | -308.987 dyne*second per centimeter^5 | Standard Deviation 378.774 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 3 hour (n=19,18,16) | -297.880 dyne*second per centimeter^5 | Standard Deviation 375.627 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 4 hour (n=19,17,16) | -339.457 dyne*second per centimeter^5 | Standard Deviation 663.324 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 5 hour (n=18,17,16) | -254.269 dyne*second per centimeter^5 | Standard Deviation 425.412 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 6 hour (n=18,17,16) | -68.635 dyne*second per centimeter^5 | Standard Deviation 508.949 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 12 hour (n=16,17,16) | -26.925 dyne*second per centimeter^5 | Standard Deviation 513.032 |
| Nesiritide (2+0.005) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 24 hour (n=14,17,14) | 68.641 dyne*second per centimeter^5 | Standard Deviation 921.094 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 4 hour (n=19,17,16) | -184.293 dyne*second per centimeter^5 | Standard Deviation 396.692 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1 hour (n=19,18,16) | -611.673 dyne*second per centimeter^5 | Standard Deviation 640.704 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 12 hour (n=16,17,16) | -327.763 dyne*second per centimeter^5 | Standard Deviation 648.264 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 5 hour (n=18,17,16) | -211.770 dyne*second per centimeter^5 | Standard Deviation 375.316 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.5 hour (n=19,18,16) | -686.497 dyne*second per centimeter^5 | Standard Deviation 784.338 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Baseline (n=19,18,16) | 2062.369 dyne*second per centimeter^5 | Standard Deviation 894.394 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 6 hour (n=18,17,16) | -189.116 dyne*second per centimeter^5 | Standard Deviation 493.764 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2.5 hour (n=19,18,16) | -220.959 dyne*second per centimeter^5 | Standard Deviation 357.619 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 2 hour (n=19,18,16) | -316.466 dyne*second per centimeter^5 | Standard Deviation 580.484 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 0.25 hour (n=19,17,16) | -384.379 dyne*second per centimeter^5 | Standard Deviation 651.98 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 3 hour (n=19,18,16) | -219.786 dyne*second per centimeter^5 | Standard Deviation 545.724 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 1.5 hour (n=19,18,16) | -370.457 dyne*second per centimeter^5 | Standard Deviation 458.264 |
| Nesiritide (2+0.01) | Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour | Change at 24 hour (n=14,17,14) | -56.456 dyne*second per centimeter^5 | Standard Deviation 477.96 |
Secondary
Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score
Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.
Time frame: Baseline, 1 h and 24 h
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 2 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 2 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0.5 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 7 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 2 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 1 hour:Score 3 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 2 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 4 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 10; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 24 hour:Score 1 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 2 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 2 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 4 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0.5 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 4 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 1 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 0 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 2 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 5 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 1 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0.5 | 0 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0.5 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 1 hour:Score 0 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 2 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0.5 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 2 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 4 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 4 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 5 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 7 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 10; at 1 hour:Score 4 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 0 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 1 | 3 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0.5 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 2 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0.5 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 2 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0.5 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 2 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0 | 3 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 0.5 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 5 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 24 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 1 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 0.5 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 3 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 2 | 3 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 4 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 4; at 24 hour:Score 3 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 3; at 1 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 2 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 1 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 0 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 10; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 4 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0.5; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 9; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 0; at 1 hour:Score 0 | 4 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 8; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 5; at 24 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 1; at 24 hour:Score 1 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 7 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0.5 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 24 hour:Score 3 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 0.5 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 2 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 6; at 24 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 1 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 7; at 1 hour:Score 0 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 1 hour:Score 0 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score | Baseline:Score 2; at 24 hour:Score 2 | 1 Participants |
Secondary
Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score
Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse
Time frame: 3, 6 and 24 hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 4 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 1 | 6 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 3 | 3 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 3 | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 2 | 3 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 1 | 5 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 2 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 2 | 3 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 4 | 3 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 4 | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 1 | 4 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 5 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 2 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 1 | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 2 | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 3 | 3 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 4 | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 5 | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 1 | 6 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 3 | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 4 | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 1 | 7 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 2 | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 3 | 1 Participants |
| Nesiritide (2+0.005) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 4 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 4 | 3 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 4 | 5 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 3 | 4 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 1 | 8 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 3 | 3 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 1 | 6 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 2 | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 2 | 5 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 1 | 4 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 2 | 2 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 6 hour: Score 3 | 5 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 3 hour: Score 5 | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score | At 24 hour: Score 4 | 3 Participants |
Secondary
Number of Participants With Orthopnea
Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms
Time frame: Baseline, 1 and 24 hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'No' | 7 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'No'; at 1 hour 'No' | 5 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'No'; at 24 hour 'No' | 6 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'Yes' | 6 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'Yes' | 1 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'No' | 7 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'Yes' | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'No' | 8 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'No'; at 24 hour 'No' | 9 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'No' | 7 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'Yes' | 4 Participants |
| Nesiritide (2+0.005) | Number of Participants With Orthopnea | Baseline: 'No'; at 1 hour 'No' | 9 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'No'; at 24 hour 'No' | 10 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'Yes' | 4 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 1 hour 'No' | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'No'; at 1 hour 'No' | 12 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'Yes' | 1 Participants |
| Nesiritide (2+0.01) | Number of Participants With Orthopnea | Baseline: 'Yes'; at 24 hour 'No' | 4 Participants |
Secondary
Number of Participants With Oxygen Therapy
Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy.
Time frame: Baseline,1 and 24 hour
Population: The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesiritide (1+ 0.01) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 1 hour 'Yes'(n=18,20,17 | 16 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Oxygen Therapy | Baseline:'No';at 24 hour 'No'(n=14,19,15) | 2 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 24 hour 'Yes'(n=14,19,15) | 12 Participants |
| Nesiritide (1+ 0.01) | Number of Participants With Oxygen Therapy | Baseline: 'No';at 1 hour 'No'(n=18,20,17) | 2 Participants |
| Nesiritide (2+0.005) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 24 hour 'Yes'(n=14,19,15) | 19 Participants |
| Nesiritide (2+0.005) | Number of Participants With Oxygen Therapy | Baseline: 'No';at 1 hour 'No'(n=18,20,17) | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Oxygen Therapy | Baseline:'No';at 24 hour 'No'(n=14,19,15) | 0 Participants |
| Nesiritide (2+0.005) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 1 hour 'Yes'(n=18,20,17 | 20 Participants |
| Nesiritide (2+0.01) | Number of Participants With Oxygen Therapy | Baseline:'No';at 24 hour 'No'(n=14,19,15) | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 1 hour 'Yes'(n=18,20,17 | 17 Participants |
| Nesiritide (2+0.01) | Number of Participants With Oxygen Therapy | Baseline: 'No';at 1 hour 'No'(n=18,20,17) | 0 Participants |
| Nesiritide (2+0.01) | Number of Participants With Oxygen Therapy | Baseline: 'Yes';at 24 hour 'Yes'(n=14,19,15) | 15 Participants |
Secondary
Urinary Volume
The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed.
Time frame: Baseline, 3 and 24 hour
Population: The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesiritide (1+ 0.01) | Urinary Volume | At 3 hour (n=19,20,17) | 539.9 Millliter | Standard Deviation 333.5 |
| Nesiritide (1+ 0.01) | Urinary Volume | Baseline (n=15,19,15) | 83.9 Millliter | Standard Deviation 69.5 |
| Nesiritide (1+ 0.01) | Urinary Volume | At 24 hour (n=19,20,17) | 1976.3 Millliter | Standard Deviation 1296 |
| Nesiritide (2+0.005) | Urinary Volume | At 3 hour (n=19,20,17) | 423.6 Millliter | Standard Deviation 289.4 |
| Nesiritide (2+0.005) | Urinary Volume | Baseline (n=15,19,15) | 67.0 Millliter | Standard Deviation 36.1 |
| Nesiritide (2+0.005) | Urinary Volume | At 24 hour (n=19,20,17) | 2296.9 Millliter | Standard Deviation 1278.7 |
| Nesiritide (2+0.01) | Urinary Volume | Baseline (n=15,19,15) | 79.7 Millliter | Standard Deviation 110.6 |
| Nesiritide (2+0.01) | Urinary Volume | At 24 hour (n=19,20,17) | 2233.6 Millliter | Standard Deviation 1569.6 |
| Nesiritide (2+0.01) | Urinary Volume | At 3 hour (n=19,20,17) | 545.1 Millliter | Standard Deviation 643.6 |