- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159627
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
January 28, 2008 updated by: NovaCardia, Inc.
A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy
The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.
Study Overview
Study Type
Interventional
Enrollment
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Sarasota, Florida, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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New Jersey
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Newark, New Jersey, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Tennessee
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Tullahoma, Tennessee, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of CHF for greater than 3 months,
- Receiving oral/IV diuretic therapy
- Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
- Signs and symptoms of ongoing volume overload
Exclusion Criteria:
- Myocardial infarction in past 14 days
- Clinical evidence of acute coronary syndrome causing worsening of HF,
- Pregnant or breast-feeding,
- Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
- Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
- Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
- Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
- Symptomatic ventricular tachycardia,
- Severe concomitant primary hepatic disease,
- Severe pulmonary disease,
- Any other concomitant life-threatening disease,
- CVA in the preceding 6 months,
- Hypotension,
- Participated in another clinical trial within 30 days,
- Acute contrast nephropathy,
- Admitted for heart transplant surgery or have had a heart transplant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in urine volume from baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 29, 2008
Last Update Submitted That Met QC Criteria
January 28, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKI-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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