Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nesiritide · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Nesiritide (1+0.01) | EXPERIMENTAL | 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. |
| Nesiritide (2+0.005) | EXPERIMENTAL | 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. |
| Nesiritide (2+0.01) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Nesiritide (1+0.01) | DRUG | 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. |
| Nesiritide (2+0.005) | DRUG | 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. |
| Nesritide (2+0.01) | DRUG | 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. |
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 fo...
Nesiritide is being studied for the treatment of congestive heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. It is in Phase 2 clinical development for this indication.
Nesiritide targets NPR1, the natriuretic peptide receptor 1. It acts as an agonist at this receptor, meaning it activates the receptor to produce its effects. NPR1 is involved in regulating blood pressure and fluid balance.
Nesiritide is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is responsible for its clinical development program.
Nesiritide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 trial has been completed.
Nesiritide has been studied in one completed Phase 2 trial, NCT00490724, titled An Exploratory Study of Nesiritide in Participants With Acute Heart Failure. The trial enrolled 67 participants in Japan and was controlled and randomized.