NCT00159627CompletedPhase 2
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
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)10 sites in 1 country52 target enrollmentStarted: August 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 10
- Primary Endpoint
- Change in urine volume from baseline
Study Overview
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 due to CHF who are refractory to high dose diuretic therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in urine volume from baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (10)
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