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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159627
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2008
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.

September 7, 2005
September 12, 2005
January 29, 2008
August 2004
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Change in urine volume from baseline
Same as current
Complete list of historical versions of study NCT00159627 on Archive Site
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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
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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Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: KW-3902IV
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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NovaCardia, Inc.
Merck Sharp & Dohme Corp.
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NovaCardia, Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP