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 used for congestive heart failure, specifically acute heart failure. It is an investigational small molecule being studied in a Phase 2 clinical trial. The drug is not approved and remains in clinical development for this cardiovascular condition.
Nesiritide is being developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is currently in Phase 2 clinical development for congestive heart failure.
Nesiritide is in Phase 2 clinical development. It is an investigational drug for congestive heart failure and has not been approved. One Phase 2 trial has been completed, and the drug is not currently in active trials.
Nesiritide has one completed Phase 2 clinical trial, NCT00490724, titled "An Exploratory Study of Nesiritide in Participants With Acute Heart Failure." The trial enrolled 67 participants in Japan and was a controlled, randomized study.
Nesiritide is a distinct drug candidate developed by Johnson & Johnson. No alternative names have been reported for this compound in the available clinical trial information.