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
Stopped early · Has a placebo group
Conditions studied: Congestive Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00568009
- Run by
- Solvay Pharmaceuticals
- People needed
- 300
- Starts
- 2007-10-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2008-04-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- 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 Martin, Argentina
- Site 8 — Santa Fe, Argentina
- Site 14 — Antwerp, Belgium
- Site 15 — Ghent, Belgium
- Site 12 — Huy, Belgium
- Site 22 — Brno, Czechia
- Site 96 — Whittier, California, United States
Full record on ClinicalTrials.gov
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