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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

This study has been terminated.
Study NCT00568009.   Last updated on April 18, 2008.   Information provided by Solvay Pharmaceuticals

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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.

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 ]
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:

  • Male and female subjects aged 18 to85 years who gave written informed consent.
  • Subjects must have a history of chronic, symptomatic, New York Heart Association (NYHA) Class II-III CHF and impaired renal function (baseline eGFR of 20 to 75 mL/min/1.73m2).
  • Congestive heart failure should have been diagnosed at least 3 months before Visit 1 (Day 1) and the subjects should be on chronic treatment with furosemide (40 mg daily) for at least 3 weeks before Visit 1 (Day 1).
  • Subjects must be on stable doses of their individually optimized medication regimen for at least 4 weeks before Visit 1 (Day 1).

Exclusion Criteria:

  • Any history of a convulsive disorder or pre-convulsive state and any risk for a convulsive disorder or pre-convulsive state (for example any past brain trauma, abuse of alcohol) will lead to an exclusion from the study.
  • Females of childbearing potential not using specified contraception, subjects with malignant tumors with a short life expectancy, subjects with known severe reactions to drugs and subjects with bilateral renal artery stenosis will be excluded from the study.
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 
Study Director:     Global Clinical Director Solvay     Solvay Pharmaceuticals    
Information Provided By Solvay Pharmaceuticals
Verification Date April 2008
First Received Date  December 4, 2007
Last Updated Date April 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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