search
Back to results

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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KW-3902IV
Sponsored by
NovaCardia, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring heart failure, congestive, diuretic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Change in urine volume from baseline

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
January 28, 2008
Sponsor
NovaCardia, Inc.
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00159627
Brief Title
Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NovaCardia, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
heart failure, congestive, diuretic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
52 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
KW-3902IV
Primary Outcome Measure Information:
Title
Change in urine volume from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Stanford
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Ayer
State/Province
Massachusetts
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Newark
State/Province
New Jersey
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Tullahoma
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs