Status:
COMPLETED
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
Lead Sponsor:
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00159627
Start Date
August 1 2004
Last Update
January 29 2008
Active Locations (10)
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1
Stanford, California, United States
2
Washington D.C., District of Columbia, United States
3
Sarasota, Florida, United States
4
Baltimore, Maryland, United States