The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function...
Date First Received: September 7, 2005
Last Updated: January 28, 2008
Verified by: NovaCardia, January 2008
Clinical Trial Phase: Phase 2 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Official Title: “Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: KW-3902IV
Outcome Measures for this Clinical Trial
Primary Measures
- Comparison of KW-3902IV alone or with loop diuretic on renal function.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Stable congestive heart failure
- Impaired renal function
- Taking oral loop diuretic
Exclusion Criteria:
- Acutely decompensated (unstable) and end stage heart failure
- Diuretics other than loop diuretics
- Pregnant or nursing
- Inability to follow instructions
- Participation in another clinical trial within past 30 days
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: NovaCardia
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159614
Study ID Number: CKI-203
ClinicalTrials.gov Identifier: NCT00159614
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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