Not Yet RecruitingPhase 2ACTRN12605000707662
A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study Of Ularitide In The Treatment Of Subjects With Acute Decompensated Heart Failure
Sponsor
Protein Design Labs, Inc.
Enrollment
200 participants
Start Date
Jan 1, 2006
Study Type
Interventional
Conditions
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
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- 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 Criteria1
- 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.
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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 s
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.
Locations(1)
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ACTRN12605000707662
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