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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.
ClinicalTrials.gov Identifier:
NCT00159627
First received: September 7, 2005
Last updated: January 28, 2008
Last verified: January 2008

September 7, 2005
January 28, 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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00159627
CKI-202
Not Provided
Not Provided
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