Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
This study has been completed.
Sponsor:
Nile Therapeutics
Information provided by:
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT00839007
First received: February 6, 2009
Last updated: September 15, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Decompensated Heart Failure |
Drug: CD-NP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure |
Resource links provided by NLM:
Further study details as provided by Nile Therapeutics:
Primary Outcome Measures:
- The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 77 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Dose 1 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Experimental: B
Dose 2 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Experimental: C
Dose 3 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Experimental: D
Dose 4 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Experimental: E
Dose 5 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Experimental: F
Dose 6 of CD-NP
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
|
Placebo Comparator: G
Placebo
|
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Hospitalized for acute decompensated heart failure.
- Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
- Renally compromised.
- Female patients must be post-menopausal or surgically sterile.
Key Exclusion Criteria:
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
- Cardiogenic shock
- Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
- Clinically significant aortic or mitral valve stenosis
- Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
- ADHF due to significant arrhythmias
- Severe renal failure defined as creatinine clearance < 30 mL/min
- Current or planned ultrafiltration, hemofiltration, or dialysis
- Significant pulmonary disease
- Major neurologic event, including cerebrovascular events in the prior 60 days.
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
- Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839007
Locations
| United States, California | |
| Los Angeles, California, United States, 90033 | |
| Torrance, California, United States, 90509 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32216 | |
| Miami Beach, Florida, United States, 33149 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52246 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, New York | |
| Bronx, New York, United States, 10467 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Germany | |
| Berlin, Germany, 12351 | |
| Berlin, Germany, 13353 | |
| Dortmund, Germany, 44137 | |
| Neuss, Germany, 41464 | |
| Wuerzberg, Germany, 97080 | |
| Israel | |
| Ashkelon, Israel, 78278 | |
| Haifa, Israel, 31096 | |
| Nazareth, Israel, 16100 | |
| Petach-Tikva, Israel, 49100 | |
| Safed, Israel, 13100 | |
| Tel Aviv, Israel, 64239 | |
Sponsors and Collaborators
Nile Therapeutics
Investigators
| Study Director: | Hsiao Lieu, MD | Nile Therapeutics |
More Information
Additional Information:
Sponsor website 
No publications provided
| Responsible Party: | Hsiao Lieu, MD, Vice President, Clinical Research, Nile Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00839007 History of Changes |
| Other Study ID Numbers: | NIL-CDNP-CT005 |
| Study First Received: | February 6, 2009 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Israel: Ministry of Health |
Keywords provided by Nile Therapeutics:
|
ADHF AHF HF |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013