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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159627
First Posted: September 12, 2005
Last Update Posted: January 29, 2008
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.
September 7, 2005
September 12, 2005
January 29, 2008
August 2004
Not Provided
Change in urine volume from baseline
Same as current
Complete list of historical versions of study NCT00159627 on ClinicalTrials.gov 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.
Not Provided
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
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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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00159627
CKI-202
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NovaCardia, Inc.
Merck Sharp & Dohme Corp.
Not Provided
NovaCardia, Inc.
January 2008

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