Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT00568009

Recruitment Status:

Terminated

Sponsor:

Solvay Pharmaceuticals

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There is 1 Location for this study

See Locations Near You

Site 96
Whittier California, , United States
Site 95
Largo Florida, , United States
Site 90
Miami Florida, , United States
Site 88
Atlanta Georgia, , United States
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Covington Georgia, , United States
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Melrose Park Illinois, , United States
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Hagerstown Maryland, , United States
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Springfield Gardens New York, , United States
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Dallas Texas, , United States
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San Antonio Texas, , United States
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Bahia Blanca , , Argentina
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Bahia Blanca , , Argentina
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Capital Federal , , Argentina
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Coronel Suarez , , Argentina
Site 1
Corrientes , , Argentina
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La Plata , , Argentina
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Mar del Plata , , Argentina
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Salta , , Argentina
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San Luis , , Argentina
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San Martin , , Argentina
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Santa Fe , , Argentina
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Antwerpen , , Belgium
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Gent , , Belgium
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Huy , , Belgium
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Brno , , Czech Republic
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Jindrichuv Hradec , , Czech Republic
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Kromeriz , , Czech Republic
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Praha , , Czech Republic
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Praha , , Czech Republic
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Semily , , Czech Republic
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Slany , , Czech Republic
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Teplice , , Czech Republic
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Belgrade , , Former Serbia and Montenegro
Site 66
Belgrade , , Former Serbia and Montenegro
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Belgrade , , Former Serbia and Montenegro
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Niska Banja , , Former Serbia and Montenegro
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Sremska Kamenica , , Former Serbia and Montenegro
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Zemun , , Former Serbia and Montenegro
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Bad Nauheim , , Germany
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Berlin , , Germany
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Dortmund , , Germany
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Bydgoszcz , , Poland
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Lublin , , Poland
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Plock , , Poland
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Skierniewice , , Poland
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Torun , , Poland
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Warszawa , , Poland
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Warszawa , , Poland
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Warszawa , , Poland
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Warszawa , , Poland
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Wroclaw , , Poland
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Zielona Gora , , Poland
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Moscow , , Russian Federation
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Moscow , , Russian Federation
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Moscow , , Russian Federation
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Moscow , , Russian Federation
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Moscow , , Russian Federation
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saint-Petersburg , , Russian Federation
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Samara , , Russian Federation
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Belville , , South Africa
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Belville , , South Africa
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Bloemfontein , , South Africa
Site 98
Durban , , South Africa
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Kempton Park , , South Africa
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Somerset West , , South Africa
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Worcester , , South Africa
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Barcelona , , Spain
Site 83
Barcelona , , Spain
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Madrid , , Spain
Site 77
Malaga , , Spain
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Santander , , Spain
Site 80
Valencia , , Spain

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

300

Study ID:

NCT00568009

Recruitment Status:

Terminated

Sponsor:


Solvay Pharmaceuticals

How clear is this clinincal trial information?

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