A Study of the Safety and Effectiveness of JNS004 (Nesiritide) in Patients With Acute Heart Failure
The objective of the study is to assess the efficacy and safety of nesiritide in patients with acute heart failure (including acute exacerbation of chronic heart failure) given intravenous (IV) bolus followed by intravenous infusion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Phase II Study of JNS004 (Nesiritide) in Patients With Acute Heart Failure|
- Change in pulmonary capillary wedge pressure (PCWP) (if it is not measurable, pulmonary arterial diastolic pressure (PADP)) from baseline at 3 hours after treatment initiation.
- Change in hemodynamics, Assessment of dyspnea and Urinary volume from baseline at 3 hours after treatment initiation.
|Study Start Date:||March 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
A multicenter, randomized (study medication assigned by chance), stepwise, open-label, bolus + intravenous infusion, fixed-flexible (arbitrary dose titration) study. As efficacy endpoints, the effects of nesiritide on hemodynamics and subjective symptoms will be assessed. In addition, plasma hBNP concentrations will be assessed to obtain information about the disposition. As exploratory endpoints, the effects of the drug on natriuretic peptide-related substances and neurohumoral factors, etc. and those on the kidney will also be assessed.To acute heart failure patients who meet the inclusion criteria in the second measurement values of systolic blood pressure (SBP) and pulmonary capillary wedge pressure (PCWP)[if it is not available, PADP(pulmonary arterial diastolic pressure)] in the hemodynamic assessment in the observation period, JNS004 will be intravenously administered at one of two dosages per kilogram of body weight. The study will be conducted stepwise, and started from the 1microgram/kg+0.01 microgram/kg/min group and 2 microgram/kg+0.005 microgram/kg/min group. Safety data as specified separately of at least 5 patients will be assessed for each group, and if there is no particular problem with the safety, the 2microgram/kg+0.01microgram/kg/min group will be started. For bolus treatment, JNS004 will be administered over 1 minute after adjusting the dosage of each patient according to the dose conversion table by weight. For intravenous infusion, JNS004 will be administered over 24 hours using a syringe pump after adjusting the dosage of each patient according to the dose conversion table by weight. JNS004 will be intravenously administered over 24 hours at one of the two dosages per kilogram of body weight. The study will be conducted stepwise, and started from 1microgram/kg+0.01 microgram/kg/minute group and 2 microgram/kg+0.005 microgram/kg/minute group.