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| Descriptive Information Fields | |||||
| Brief Title † | Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function | ||||
| Official Title † | Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Sequential Cohort Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function | ||||
| Brief Summary | This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (CHF) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each increasing dose level of SLV320 or placebo in a sequential fashion. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| Primary Outcome Measure † | Cystatine C [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Sodium in urine [ Time Frame: 3 months ] [ Designated as safety issue: No ] Estimated glomerular filtration rate [ Time Frame: 3 months ] [ Designated as safety issue: No ] Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ] Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ] |
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| Condition † | Congestive Heart Failure | ||||
| Intervention † | Drug: SLV320 | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 300 | ||||
| Start Date † | October 2007 | ||||
| Completion Date | November 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States, Argentina, Belgium, Czech Republic, Germany, Poland, Russian Federation, Serbia and Montenegro, South Africa, Spain | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00568009 | ||||
| Organization ID | S320.2.003 | ||||
| Secondary IDs †† | 2007-000490-40 | ||||
| Study Sponsor † | Solvay Pharmaceuticals | ||||
| Collaborators †† | Quintiles | ||||
| Investigators † |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | December 4, 2007 | ||||
| Last Updated Date | April 18, 2008 | ||||