A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled,

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2005
INTERVENTION: 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. CONDITION: Acute Decompensated Heart Failure PRIMARY OUTCOME: To compare the efficacy of ularitide ; (15 ng/kg/min IV over 24 hours) to placebo in subjects with ; symptomatic acute decompensated heart failure. To compare the safety of ularitide ; (15 ng/kg/min IV over 24 hours) to placebo in subjects with ; symptomatic acute decompensated heart failure. SECONDARY OUTCOME: To evaluate the pharmacokinetics, pharmacodynamics, ; and immunogenicity of IV ularitide in subjects with symptomatic ; ADHF. 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).
Epistemonikos ID: 4837e4be120e15575a81a9487d134ba286e0e95e
First added on: Aug 21, 2024