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
NCT ID: NCT00568009
Last Updated: 2008-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
300 participants
OBSERVATIONAL
2007-10-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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SLV320
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Quintiles, Inc.
INDUSTRY
Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 96
Whittier, California, United States
Site 95
Largo, Florida, United States
Site 90
Miami, Florida, United States
Site 88
Atlanta, Georgia, United States
Site 92
Covington, Georgia, United States
Site 106
Melrose Park, Illinois, United States
Site 87
Hagerstown, Maryland, United States
Site 94
Springfield Gardens, New York, United States
Site 89
Dallas, Texas, United States
Site 97
San Antonio, Texas, United States
Site 11
Bahía Blanca, , Argentina
Site 2
Bahía Blanca, , Argentina
Site 101
Capital Federal, , Argentina
Site 6
Coronel Suárez, , Argentina
Site 1
Corrientes, , Argentina
Site 5
La Plata, , Argentina
Site 104
Mar del Plata, , Argentina
Site 102
Salta, , Argentina
Site 105
San Luis, , Argentina
Site 4
San Martín, , Argentina
Site 8
Santa Fe, , Argentina
Site 14
Antwerp, , Belgium
Site 15
Ghent, , Belgium
Site 12
Huy, , Belgium
Site 22
Brno, , Czechia
Site 16
Jindřichův Hradec, , Czechia
Site 19
Kroměříž, , Czechia
Site 20
Prague, , Czechia
Site 21
Prague, , Czechia
Site 17
Semily, , Czechia
Site 18
Slaný, , Czechia
Site 23
Teplice, , Czechia
Site 24
Bad Nauheim, , Germany
Site 28
Berlin, , Germany
Site 26
Dortmund, , Germany
Site 50
Bydgoszcz, , Poland
Site 47
Lublin, , Poland
Site 49
Płock, , Poland
Site 57
Skierniewice, , Poland
Site 54
Torun, , Poland
Site 48
Warsaw, , Poland
Site 52
Warsaw, , Poland
Site 53
Warsaw, , Poland
Site 56
Warsaw, , Poland
Site 55
Wroclaw, , Poland
Site 51
Zielona Góra, , Poland
Site 58
Moscow, , Russia
Site 61
Moscow, , Russia
Site 62
Moscow, , Russia
Site 63
Moscow, , Russia
Site 64
Moscow, , Russia
Site 60
Saint Petersburg, , Russia
Site 59
Samara, , Russia
Site 65
Belgrade, , Serbia and Montenegro
Site 66
Belgrade, , Serbia and Montenegro
Site 69
Belgrade, , Serbia and Montenegro
Site 68
Niska Banja, , Serbia and Montenegro
Site 67
Sremska Kamenica, , Serbia and Montenegro
Site 70
Zemun, , Serbia and Montenegro
Site 72
Belville, , South Africa
Site 75
Belville, , South Africa
Site 76
Bloemfontein, , South Africa
Site 98
Durban, , South Africa
Site 73
Kempton Park, , South Africa
Site 71
Somerset West, , South Africa
Site 74
Worcester, , South Africa
Site 78
Barcelona, , Spain
Site 83
Barcelona, , Spain
Site 79
Madrid, , Spain
Site 77
Málaga, , Spain
Site 82
Santander, , Spain
Site 80
Valencia, , Spain
Countries
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Other Identifiers
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2007-000490-40
Identifier Type: -
Identifier Source: secondary_id
S320.2.003
Identifier Type: -
Identifier Source: org_study_id