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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 7, 2005 |
| Last Updated Date | January 28, 2008 |
| Start Date ICMJE | September 2005 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
Comparison of KW-3902IV alone or with loop diuretic on renal function. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00159614 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment |
| Official Title ICMJE | Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment |
| Brief Summary | The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: KW-3902IV |
| Study Arms / Comparison Groups | |
| Publications * | Dittrich HC, Gupta DK, Hack TC, Dowling T, Callahan J, Thomson S. The effect of KW-3902, an adenosine A1 receptor antagonist, on renal function and renal plasma flow in ambulatory patients with heart failure and renal impairment. J Card Fail. 2007 Oct;13(8):609-17. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 30 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 ID ICMJE | NCT00159614 |
| Responsible Party | |
| Study ID Numbers ICMJE | CKI-203 |
| Study Sponsor ICMJE | NovaCardia |
| Collaborators ICMJE | Merck |
| Investigators ICMJE | |
| Information Provided By | NovaCardia |
| Verification Date | January 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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