Tracking Information
Start Date ICMJE | May 2007 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: February 14, 2008) | Rehospitalization due to heart failure and all-cause mortality from randomization through Day 30 and dyspnea symptoms as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation. [ Time Frame: Rehospitalization due to heart failure and all-cause mortality from randomization through Day 30 and dyspnea symptoms at 6 hours or 24 hours after study drug initiation. ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: May 18, 2007) | Rehospitalization due to heart failure and all-cause mortality from randomization through Day 30 and dyspnea symptoms as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation. |
Change History | Complete list of historical versions of study NCT00475852 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 14, 2008) | Overall well-being as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation. The number of days alive and outside the hospital from randomization through Day 30 [ Time Frame: Overall well-being at 6 hours or 24 hours after study drug initiation. The number of days alive and outside the hospital from randomization through Day 30 ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE (submitted: May 18, 2007) | Overall well-being as measured by subject self-assessed Likert scale at 6 hours or 24 hours after study drug initiation. The number of days alive and outside the hospital from randomization through Day 30 |
Descriptive Information
Brief Title ICMJE | A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure |
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Official Title ICMJE | Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure (ASCEND-HF) |
Brief Summary | The purpose of this study is to find out if Nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce readmissions to hospitals, and helps patients live longer. |
Detailed Description | Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo [does not contain study drug]), placebo-controlled, parallel group, multicenter study of the effectiveness of Nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that Nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after Nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (Nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of Nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the Nesiritide group will receive a continuous i.v. (into a vein) infusion at 0.010 mcg/kg/min of Nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Heart Decompensation |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 7000 | ||||
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Estimated Completion Date | June 2010 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, India, Israel, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Singapore, Sweden, Taiwan, Thailand, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00475852 | ||||
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Responsible Party | Vice President, Associate Therapeutic Area Head, Scios RD, Inc. | ||||
Study ID Numbers ICMJE | CR013954, NATRECORAHF3002, ASCEND-HF, A093 | ||||
Study Sponsor ICMJE | Scios, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Scios, Inc. |