drugset / Trial / NCT00652652

Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS

NCT00652652

Phase 4 Completed Scios, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This is a randomized, open-label, three-way crossover design study with 3 treatment groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an infusion for 6 hours;TREATMENT C: Treatment B for at least 15 minutes, then administration of treatment AAll sequences involving both furosemide and nesiritide had the nesiritide infusion started first, at least 15 minutes before furosemide was administered. Each treatment will be administered according to 1 of 6 sequences to which patients are randomized. Patients will remain in the Clinical Research Unit for 7 days, with treatments administered on Days 2, 4, and 6, with equilibrium (rest) days on Days 1, 3, and 5. All patients will be followed for safety throughout the treatment phase, and by telephone between 7 and 14 days after they are discharged from the Clinical Research Unit.

Timeline

Start
2003-03
Primary completion
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 40 mg Intravenous
Subject Nesiritide Protein / enzyme biologic 0.01 ug/kg Intravenous