Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
NCT ID: NCT00839007
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
Dose 1 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
B
Dose 2 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
C
Dose 3 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
D
Dose 4 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
E
Dose 5 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
F
Dose 6 of CD-NP
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
G
Placebo
CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Interventions
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CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Eligibility Criteria
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Inclusion Criteria
2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
3. Renally compromised.
4. Female patients must be post-menopausal or surgically sterile.
Exclusion Criteria
2. Cardiogenic shock
3. Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
4. Clinically significant aortic or mitral valve stenosis
5. Temperature \>38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
6. ADHF due to significant arrhythmias
7. Severe renal failure defined as creatinine clearance \< 30 mL/min
8. Current or planned ultrafiltration, hemofiltration, or dialysis
9. Significant pulmonary disease
10. Major neurologic event, including cerebrovascular events in the prior 60 days.
11. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
12. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
18 Years
85 Years
ALL
No
Sponsors
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Nile Therapeutics
INDUSTRY
Responsible Party
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Nile Therapeutics, Inc.
Principal Investigators
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Hsiao Lieu, MD
Role: STUDY_DIRECTOR
Nile Therapeutics
Locations
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Los Angeles, California, United States
Torrance, California, United States
Jacksonville, Florida, United States
Miami Beach, Florida, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
The Bronx, New York, United States
Houston, Texas, United States
Berlin, , Germany
Berlin, , Germany
Dortmund, , Germany
Neuss, , Germany
Würzberg, , Germany
Ashkelon, , Israel
Haifa, , Israel
Nazareth, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Countries
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Other Identifiers
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NIL-CDNP-CT005
Identifier Type: -
Identifier Source: org_study_id