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| Descriptive Information Fields | |||||||||
| Brief Title † | Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF) | ||||||||
| Official Title † | Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF) | ||||||||
| Brief Summary | To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Changes in cardiac output and wedge pressure [ Time Frame: 8 hours ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Changes in additional hemodynamic measures [ Time Frame: 8 hours ] [ Designated as safety issue: No ] Diuresis and natriuresis during and after administration of study drug [ Time Frame: 36 hour ] [ Designated as safety issue: No ] Safety of CD-NP [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ] |
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| Condition † | Acute Decompensated Heart Failure | ||||||||
| Intervention † | Drug: CD-NP (Chimeric natriuretic peptide) | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Sponsor ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 30 | ||||||||
| Start Date † | June 2008 | ||||||||
| Completion Date | December 2008 | ||||||||
| Eligibility Criteria † | Key Inclusion Criteria:
Key Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Russian Federation | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00699712 | ||||||||
| Organization ID | NIL-CDNP-CT003 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Nile Therapeutics | ||||||||
| Collaborators †† | Momentum Research Inc. | ||||||||
| Investigators † |
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| Information Provided By | Nile Therapeutics | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | June 10, 2008 | ||||||||
| Last Updated Date | October 19, 2008 | ||||||||