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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.
( additional enrolment criteria made patients' recruitment not feasible anymore )
Study NCT00568009   Information provided by Solvay Pharmaceuticals
First Received: December 4, 2007   Last Updated: April 18, 2008   History of Changes

December 4, 2007
April 18, 2008
October 2007
November 2008   (final data collection date for primary outcome measure)
Cystatine C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568009 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
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
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

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.

 
 
Observational
Cohort, Prospective
Congestive Heart Failure
Drug: SLV320
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
300
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Czech Republic,   Germany,   Poland,   Russian Federation,   Serbia and Montenegro,   South Africa,   Spain
 
NCT00568009
Kay-Christen Meyer, Solvay Pharmaceuticals
S320.2.003, 2007-000490-40
Solvay Pharmaceuticals
Quintiles
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP