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 - Full Text View

Sponsor:	Solvay Pharmaceuticals
Collaborator:	Quintiles
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00568009

Purpose

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	Intervention
Congestive Heart Failure	Drug: SLV320

Study Type:	Observational
Study Design:	Cohort, 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Furosemide

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Cystatine C [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sodium in urine [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Estimated glomerular filtration rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Body weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Not aplicable

Estimated Enrollment:	300
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568009

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Locations

United States, California
Site 96
Whittier, California, United States
United States, Florida
Site 90
Miami, Florida, United States
Site 95
Largo, Florida, United States
United States, Georgia
Site 88
Atlanta, Georgia, United States
Site 92
Covington, Georgia, United States
United States, Illinois
Site 106
Melrose Park, Illinois, United States
United States, Maryland
Site 87
Hagerstown, Maryland, United States
United States, New York
Site 94
Springfield Gardens, New York, United States
United States, Texas
Site 89
Dallas, Texas, United States
Site 97
San Antonio, Texas, United States
Argentina
Site 11
Bahia Blanca, Argentina
Site 4
San Martin, Argentina
Site 5
La Plata, Argentina
Site 6
Coronel Suarez, Argentina
Site 102
Salta, Argentina
Site 2
Bahia Blanca, Argentina
Site 101
Capital Federal, Argentina
Site 8
Santa Fe, Argentina
Site 104
Mar del Plata, Argentina
Site 1
Corrientes, Argentina
Site 105
San Luis, Argentina
Belgium
Site 12
Huy, Belgium
Site 14
Antwerpen, Belgium
Site 15
Gent, Belgium
Czech Republic
Site 16
Jindrichuv Hradec, Czech Republic
Site 17
Semily, Czech Republic
Site 18
Slany, Czech Republic
Site 19
Kromeriz, Czech Republic
Site 20
Praha, Czech Republic
Site 21
Praha, Czech Republic
Site 22
Brno, Czech Republic
Site 23
Teplice, Czech Republic
Former Serbia and Montenegro
Site 70
Zemun, Former Serbia and Montenegro
Site 66
Belgrade, Former Serbia and Montenegro
Site 69
Belgrade, Former Serbia and Montenegro
Site 65
Belgrade, Former Serbia and Montenegro
Site 68
Niska Banja, Former Serbia and Montenegro
Site 67
Sremska Kamenica, Former Serbia and Montenegro
Germany
Site 28
Berlin, Germany
Site 26
Dortmund, Germany
Site 24
Bad Nauheim, Germany
Poland
Site 50
Bydgoszcz, Poland
Site 48
Warszawa, Poland
Site 49
Plock, Poland
Site 47
Lublin, Poland
Site 51
Zielona Gora, Poland
Site 52
Warszawa, Poland
Site 53
Warszawa, Poland
Site 54
Torun, Poland
Site 55
Wroclaw, Poland
Site 56
Warszawa, Poland
Site 57
Skierniewice, Poland
Russian Federation
Site 58
Moscow, Russian Federation
Site 59
Samara, Russian Federation
Site 60
saint-Petersburg, Russian Federation
Site 61
Moscow, Russian Federation
Site 62
Moscow, Russian Federation
Site 63
Moscow, Russian Federation
Site 64
Moscow, Russian Federation
South Africa
Site 74
Worcester, South Africa
Site 71
Somerset West, South Africa
Site 73
Kempton Park, South Africa
Site 72
Belville, South Africa
Site 76
Bloemfontein, South Africa
Site 75
Belville, South Africa
Site 98
Durban, South Africa
Spain
Site 83
Barcelona, Spain
Site 79
Madrid, Spain
Site 77
Malaga, Spain
Site 82
Santander, Spain
Site 78
Barcelona, Spain
Site 80
Valencia, Spain

Sponsors and Collaborators

Solvay Pharmaceuticals

Quintiles

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Kay-Christen Meyer )
Study ID Numbers:	S320.2.003, 2007-000490-40
Study First Received:	December 4, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00568009 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Solvay Pharmaceuticals:

Congestive Heart Failure
Impaired Renal Function

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Furosemide

Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on November 20, 2009