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
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Drug: KW-3902IV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by NovaCardia, Inc.:

Primary Outcome Measures:
  • Change in urine volume from baseline

Estimated Enrollment: 52
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159627

Locations
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 Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159627     History of Changes
Other Study ID Numbers: CKI-202
Study First Received: September 7, 2005
Last Updated: January 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NovaCardia, Inc.:
heart failure, congestive
diuretic

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
1,3-dipropyl-8-(3-noradamantyl)xanthine
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014