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| Sponsors and Collaborators: |
Nile Therapeutics Momentum Research Inc. |
| Information provided by: | Nile Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00699712 |
Purpose
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
| Condition | Intervention | Phase |
|
Acute Decompensated Heart Failure |
Drug: CD-NP (Chimeric natriuretic peptide) |
Phase II |
| MedlinePlus related topics: | Heart Failure |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| 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) |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Experimental
Open-label regimen of doses 1 and 2 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
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B: Experimental
Open-label regimen of doses 2 and 3 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
|
C: Experimental
Open-label regimen of doses 3 and 4 of CDNP
|
Drug: CD-NP (Chimeric natriuretic peptide)
Infusion of CDNP at two of four doses
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations| Contact: Nancy Vinh | 415-875-7885 | nvinh@nilethera.com |
| Contact: Jennifer Hodge | 415-875-7884 | jhodge@nilethera.com |
| Russian Federation, Russia | |||||
| Russian Academy of Medical Sciences | Recruiting | ||||
| Moscow, Russia, Russian Federation, 121552 | |||||
| Nile Therapeutics |
| Momentum Research Inc. |
| Study Director: | Hsiao Lieu, MD | Nile Therapeutics Inc. |
| Study Director: | Gad Cotter, MD | Momentum Research Inc. |
More Information
Sponsor 
  |
| Responsible Party: | Nile Therapeutics ( Hsiao Lieu, MD / Vice President, Clinical Research ) |
| Study ID Numbers: | NIL-CDNP-CT003 |
| First Received: | June 10, 2008 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00699712 |
| Health Authority: | Israel: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health |
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