Trial | NCT00159627  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
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 Started
Aug 31
2004
Last Update
Jan 29
2008
Estimate

Drug KW-3902IV

Criteria 

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.
No Results Posted