Study Stopped
additional enrolment criteria made patients' recruitment not feasible anymore
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
2 other identifiers
observational
300
10 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedApril 22, 2008
April 1, 2008
1.1 years
December 4, 2007
April 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cystatine C
3 months
Secondary Outcomes (4)
Sodium in urine
3 months
Estimated glomerular filtration rate
3 months
Clinical global impression
3 months
Body weight
3 months
Interventions
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
Eligibility Criteria
Congestive Heart Failure, Impaired Renal Function
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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solvay Pharmaceuticalslead
- Quintiles, Inc.collaborator
Study Sites (72)
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
Biospecimen
Not aplicable
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 5, 2007
Study Start
October 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
April 22, 2008
Record last verified: 2008-04