A Study of Ularitide in the Treatment of Subjects With Acute Decompensated Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00487799|
Recruitment Status : Withdrawn (Facet no longer has ownership of ularitide.)
First Posted : June 19, 2007
Last Update Posted : July 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Drug: Ularitide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|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|
- The MTD of ularitide infused over 48 hours.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|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|