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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.
 
ClinicalTrials.gov Identifier: NCT00159627
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2008
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by:
NovaCardia, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: KW-3902IV Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in urine volume from baseline

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159627


Locations
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United States, California
Stanford, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Sarasota, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Ayer, Massachusetts, United States
Boston, Massachusetts, United States
United States, New Jersey
Newark, New Jersey, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Tullahoma, Tennessee, United States
Sponsors and Collaborators
NovaCardia, Inc.
Merck Sharp & Dohme LLC
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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ClinicalTrials.gov Identifier: NCT00159627    
Other Study ID Numbers: CKI-202
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008
Keywords provided by NovaCardia, Inc.:
heart failure, congestive
diuretic
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Rolofylline
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs