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The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Dose 1 of CD-NP |
|
| B | Experimental | Dose 2 of CD-NP |
|
| C | Experimental | Dose 3 of CD-NP |
|
| D | Experimental | Dose 4 of CD-NP |
|
| E | Experimental | Dose 5 of CD-NP |
|
| F | Experimental | Dose 6 of CD-NP |
|
| G | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD-NP | Drug | Infusion of CD-NP at one of up to 6 doses or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. | Up to 72 hours |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsiao Lieu, MD | Nile Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90033 | United States | |||
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| Label | URL |
|---|---|
| Sponsor website | View source |
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Placebo
|
| Torrance |
| California |
| 90509 |
| United States |
| Jacksonville | Florida | 32216 | United States |
| Miami Beach | Florida | 33149 | United States |
| Chicago | Illinois | 60611 | United States |
| Iowa City | Iowa | 52246 | United States |
| Detroit | Michigan | 48201 | United States |
| Minneapolis | Minnesota | 55415 | United States |
| The Bronx | New York | 10467 | United States |
| Houston | Texas | 77030 | United States |
| Berlin | 12351 | Germany |
| Berlin | 13353 | Germany |
| Dortmund | 44137 | Germany |
| Neuss | 41464 | Germany |
| Würzberg | 97080 | Germany |
| Ashkelon | 78278 | Israel |
| Haifa | 31096 | Israel |
| Nazareth | 16100 | Israel |
| Petah Tikva | 49100 | Israel |
| Safed | 13100 | Israel |
| Tel Aviv | 64239 | Israel |