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

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

NovaCardia, Inc.

ClinicalTrials.gov Identifier:

NCT00159627

First received: September 7, 2005

Last updated: January 28, 2008

Last verified: January 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 7, 2005
Last Updated Date	January 28, 2008
Start Date ^ICMJE	August 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 7, 2005)	Change in urine volume from baseline
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00159627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Heart Failure, Congestive
Intervention ^ICMJE	Drug: KW-3902IV
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00159627
Other Study ID Numbers ^ICMJE	CKI-202
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	NovaCardia, Inc.
Collaborators ^ICMJE	Merck
Investigators ^ICMJE	Not Provided
Information Provided By	NovaCardia, Inc.
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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