Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS
NCT00652652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2011-05-19
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.
Conditions
- Congestive Heart Failure
- Chronic Heart Failure
Interventions
- DRUG
-
nesiritide, furosemide
Sponsors & Collaborators
-
Scios, Inc.
lead INDUSTRY
Principal Investigators
-
Scios, Inc. Clinical Trial · Scios, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Completion
- 2004-01-31
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