A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled,Multicenter Study Of Ularitide In The Treatment Of Subjects WithAcute Decompensated Heart Failure
- Conditions
- Acute Decompensated Heart FailureCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12605000707662
- Lead Sponsor
- Protein Design Labs, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the safety of ularitide<br>(15 ng/kg/min IV over 24 hours) to placebo in subjects with<br>symptomatic acute decompensated heart failure.[];To compare the efficacy of ularitide<br>(15 ng/kg/min IV over 24 hours) to placebo in subjects with<br>symptomatic acute decompensated heart failure.[]
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics, pharmacodynamics,<br>and immunogenicity of IV ularitide in subjects with symptomatic<br>ADHF.[]