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| Sponsor: | Nile Therapeutics |
|---|---|
| Collaborator: |
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 |
| 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 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 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
|
|
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| Russian Federation, Russia | |
| Russian Academy of Medical Sciences | |
| Moscow, Russia, Russian Federation, 121552 | |
| Study Director: | Hsiao Lieu, MD | Nile Therapeutics Inc. |
| Study Director: | Gad Cotter, MD | Momentum Research, Inc. |
More Information
| Responsible Party: | Nile Therapeutics ( Hsiao Lieu, MD / Vice President, Clinical Research ) |
| Study ID Numbers: | NIL-CDNP-CT003 |
| Study First Received: | June 10, 2008 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00699712 History of Changes |
| Health Authority: | Israel: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health |
|
ADHF AHF HF |
|
Heart Failure Heart Diseases Cardiovascular Diseases |