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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

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ClinicalTrials.gov Identifier: NCT00568009
Recruitment Status : Terminated (additional enrolment criteria made patients' recruitment not feasible anymore)
First Posted : December 5, 2007
Last Update Posted : April 22, 2008
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by:
Solvay Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Congestive Heart Failure Drug: SLV320

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

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Groups and Cohorts
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Intervention Details:
  • Drug: SLV320
    1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Outcome Measures
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Primary Outcome Measures :
  1. Cystatine C [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Sodium in urine [ Time Frame: 3 months ]
  2. Estimated glomerular filtration rate [ Time Frame: 3 months ]
  3. Clinical global impression [ Time Frame: 3 months ]
  4. Body weight [ Time Frame: 3 months ]

Biospecimen Retention:   None Retained
Not aplicable

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Study Population
Congestive Heart Failure, Impaired Renal Function
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568009


Locations
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Sponsors and Collaborators
Solvay Pharmaceuticals
Quintiles, Inc.
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information
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Responsible Party: Kay-Christen Meyer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00568009    
Other Study ID Numbers: S320.2.003
2007-000490-40
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Keywords provided by Solvay Pharmaceuticals:
Congestive Heart Failure
Impaired Renal Function
Additional relevant MeSH terms:
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Renal Insufficiency
Heart Failure
Heart Diseases
 Cardiovascular Diseases
Kidney Diseases
Urologic Diseases