An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for 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: NCT00813202|
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : February 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heart Decompensation Congestive Heart Failure||Drug: Nesiritide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Arm, Multi-centered Clinical Trial on the Hemodynamics and Safety of Nesiritide in the Treatment of Patients With Acute Decompensate Heart Failure|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
- Change in pulmonary capillary wedge pressure [ Time Frame: Baseline, 180 days ]Pulmonary capillary wedge pressure will be measured in patients at all time points after administration of nesiritide, and the difference will be compared with baseline value (P<0.001).
- Change in clinical symptoms and overall clinical efficacy [ Time Frame: Baseline, 180 days ]Nesiritide will attenuate dyspnoea. Nesiritide will also improve clinical symptoms and Nesiritide will improve overall clinical efficacy.
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): NCT00813202
|Study Director:||Xian-Janssen Pharmaceutical Ltd. Clinical Trial||Xian-Janssen Pharmaceutical Ltd.|