CLINICAL TRIALS PROFILE FOR NESIRITIDE

All Clinical Trials for nesiritide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075179 ↗	Natrecor in Pulmonary Hypertension	Terminated	M.D. Anderson Cancer Center	Phase 4	2003-12-31	The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.
NCT00083772 ↗	Use of Nesiritide in the Management of Acute Diastolic Heart Failure	Terminated	M.D. Anderson Cancer Center	Phase 4	2004-05-17	Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure. Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
NCT00091520 ↗	A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure	Completed	Scios, Inc.	Phase 2	2004-04-01	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.
NCT00110201 ↗	The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure	Unknown status	Ejaz, Abulate A, MD	Phase 3	2005-03-01	The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure. The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.
NCT00119691 ↗	Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction	Completed	Scios, Inc.	Phase 2	2003-04-01	The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
NCT00119691 ↗	Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction	Completed	Brigham and Women's Hospital	Phase 2	2003-04-01	The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
NCT00145873 ↗	Nesiritide in Chronic Heart Failure	Terminated	Scios, Inc.	Phase 2	2003-08-01	The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure. Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III & IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period. Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing. Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.

Clinical Trial Conditions for nesiritide

Condition Name

Condition Name for nesiritide
Intervention	Trials
Congestive Heart Failure	13
Heart Failure, Congestive	12
Heart Failure	9
Hypertension	6

Condition MeSH

Condition MeSH for nesiritide
Intervention	Trials
Heart Failure	40
Hypertension	8
Renal Insufficiency	7
Cardiomyopathies	5

Clinical Trial Locations for nesiritide

Trials by Country

Trials by Country for nesiritide
Location	Trials
United States	95
Canada	7
China	3
Australia	2
Norway	2

Trials by US State

Trials by US State for nesiritide
Location	Trials
Minnesota	14
Florida	7
Massachusetts	6
Texas	6
Tennessee	5

Clinical Trial Progress for nesiritide

Clinical Trial Phase

Clinical Trial Phase for nesiritide
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	13
Phase 2	11

Clinical Trial Status

Clinical Trial Status for nesiritide
Clinical Trial Phase	Trials
Completed	34
Terminated	15
Withdrawn	7

Clinical Trial Sponsors for nesiritide

Sponsor Name

Sponsor Name for nesiritide
Sponsor	Trials
Scios, Inc.	26
Mayo Clinic	9
National Center for Research Resources (NCRR)	6

Sponsor Type

Sponsor Type for nesiritide
Sponsor	Trials
Other	60
Industry	32
NIH	13