None listed
Conditions
Brief summary
Nepean Hospital Derby Street Penrith NSW 2751 ethics submission due on 12th Oct 05. Royal Adelaide Hospital Level 6, Outpatients Building North Terrace, SA 5000 ethics submission 19th Oct 05
Interventions
This is a randomized, 2-arm study in which ularitide (15 ng/kg/min) or placebo will
be administered IV continuously over 24 hours, in addition to standard therapy. Subjects must receive the dose of study drug within one hour after
randomization.
Sponsors
Protein Design Labs, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults who require hospitalization in a monitored bed for ADHF. Symptomatic ADHF (see Section 4.2 for definingcharacteristics). A negative urine pregnancy test result in women ofchildbearing potential within 24 hours of dosing. Ability of subject or authorized guardian to provide informedconsent (all sites) and permission to use protected health information (US sites only).
Exclusion criteria
Systolic blood pressure (BP) 110 or >200 mmHg at screening and within 10 minutes of study drug administration. Ongoing acute coronary syndrome, acute myocarditis orconstrictive pericarditis, obstructive hypertrophiccardiomyopathy, hemodynamically significant arrhythmias, stenotic valvular disease, or congenital heart disease; acutemyocardial infarction within 30 days of randomization. Use of restricted medications or procedures (see details in Section 4.3). Cardiogenic shock, volume depletion, severe electrolyteimbalance, renal disorder with serum creatinine >2.5 mg/dL (220 micromol/L) or planned ultrafiltration or dialysis or anyother clinical condition that would contraindicate the use of an IV vasodilator. Coronary artery bypass grafting within 90 days. Suspicion of pulmonary embolism. Cerebrovascular accident (CVA) within 180 days.
Outcome results
None listed