A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure

Phase 2 Completed 920 enrolled Scios, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.

Timeline

Start: 2004-04
Primary completion: —
Completion: 2006-12

Outcome

Missed primary endpoint

paper The primary end point occurred in 36.8% and 36.7% of the placebo and nesiritide groups, respectively PMID 19808265 ↗

paper hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P=0.79 PMID 19808265 ↗

Publications

Yancy CW, Krum H, Massie BM, Silver MA, Stevenson LW, Cheng M, Kim SS, Evans R; FUSION II Investigators. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Circ Heart Fail. 2008 May;1(1):9-16. doi: 10.1161/CIRCHEARTFAILURE.108.767483.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nesiritide	Protein / enzyme biologic	0.01 ug/kg	Intravenous