An Exploratory Study of Nesiritide in Participants With Acute Heart Failure

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

July 31, 2008

Conditions
Heart Failure, Congestive
Interventions
DRUG

Nesiritide (1+0.01)

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.

DRUG

Nesiritide (2+0.005)

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.

DRUG

Nesritide (2+0.01)

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.

Trial Locations (11)

Unknown

Amagasaki

Chikushino-shi

Hiroshima

Ikoma

Komatsushima

Kumamoto

Moriyama

Osaka

Saitama

Tokyo

Yokohama

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY