A Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure
This study has been withdrawn prior to enrollment.
(Facet no longer has ownership of ularitide.)
Information provided by:
First received: June 15, 2007
Last updated: July 17, 2009
Last verified: July 2009
To determine the maximum tolerated dose (MTD) of ularitide in the treatment of subjects hospitalized with symptomatic acute decompensated heart failure (ADHF).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure|
Resource links provided by NLM:
Further study details as provided by Facet Biotech:
Primary Outcome Measures:
- The MTD of ularitide infused over 48 hours.
Secondary Outcome Measures:
- Frequency, severity, and relationship of AEs and serious adverse events (SAEs) to study drug through Day 32 (ie, 30 days following the end of study drug infusion).
- Physical examinations, vital signs, electrocardiography, and clinical laboratory values through 48 hours.
- Decline in renal function defined as a >25% rise or a 0.3 mg/dL increase in serum creatinine from pre-dose at baseline to 48 hours post the end of infusion and through Day 32.
- Pharmacokinetic profile including Css, AUC, CL, V, and t½ up to 2 hours post end of infusion.
- Incidence of ularitide-specific anti-drug antibodies (ADAb) through Day 32.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487799
|United States, California|
|UCSD Medical Center|
|San Diego, California, United States, 92103|
|United States, Georgia|
|The Atlanta Cardiology Group, PC|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Feinberg School of Medicine, Northwestern Univ.|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Cardiovascular Specialists PC dba New York Heart Ctr.|
|Syracuse, New York, United States, 13210|
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|United States, Tennessee|
|Kore Cardiovascular Research Institute|
|Lexington, Tennessee, United States, 38351|
Sponsors and Collaborators
|Principal Investigator:||William Cotts, MD||Feinberg School of Medicine, Northwestern Univ.|
|Principal Investigator:||Gregory Ewald, MD||Washington University School of Medicine|
|Principal Investigator:||Daniel Fuleihan, MD||Cardiovascular Specialists PC dba New York Heart Ctr|
|Principal Investigator:||Barry Greenberg, MD||UCSD Medical Center|
|Principal Investigator:||Darshak Karia, MD||Albert Einstein Medical Center|
|Principal Investigator:||Elie Korban, MD||Kore Cardiovascular Research Institute|
|Principal Investigator:||Richard Nowak, MD||Henry Ford Health System|
|Principal Investigator:||Nirav Y. Raval, MD||The Atlanta Cardiology Group, PC|