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

This study has been terminated.

( additional enrolment criteria made patients' recruitment not feasible anymore )

First Received: December 4, 2007 Last Updated: April 18, 2008 History of Changes

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

Show 72 Study Locations

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 22, 2009