Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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KW-3902IV

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No