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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 is currently recruiting participants.
Verified by Solvay Pharmaceuticals, December 2007
Sponsors and Collaborators: Solvay Pharmaceuticals
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
MedlinePlus related topics: Heart Failure
ChemIDplus related topics: Furosemide
U.S. FDA Resources
Study Type: Observational
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
Further study details as provided by Solvay Pharmaceuticals:
Estimated Enrollment: 300
Study Start Date: October 2007
Eligibility
Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
To compare five SLV320 doses (1, 2.5, 5, 10 and 20 mg orally twice daily) to placebo regarding the change from baseline in cystatin C at endpoint
Exclusion Criteria:
To compare five SLV320 doses (1, 2.5, 5, 10 and 20 mg orally twice daily) to placebo regarding the change in the following variables from baseline to all relevant post-baseline treatment visits: Cystatin C;
The concentration of sodium, potassium, chloride, creatinine, uric acid, adenosine and albumin in a spot urine sample;
The fractional excretion of sodium, potassium, chloride, creatinine, uric acid and albumin in urine;
Estimated glomerular filtration rate (eGFR);
Total daily dose of furosemide;
Body weight;
Plasma catecholamines, NT-proBNP, angiotensin II, aldosterone and high sensitive C-reactive protein;
Troponin I, glycosylated hemoglobin (HbA1c), fasting glucose, fasting insulin, calcium and magnesium;
Biomarkers for cardiac remodeling;
Clinical global impression;
Dose-response relationship for cystatin C, sodium and eGFR.
To evaluate the trough plasma concentrations prior to the morning dose of five SLV320 doses (1, 2.5, 5, 10 and 20 mg orally twice daily)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568009
Contacts
Contact: Kay-Christen Meyer kay-christen.meyer@solvay.com
Show 71 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Quintiles
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information
Study ID Numbers: S320.2.003, 2007-000490-40
First Received: December 4, 2007
Last Updated: December 4, 2007
ClinicalTrials.gov Identifier: NCT00568009
Health Authority: United States: Food and Drug Administration; Belgium:
Keywords provided by Solvay Pharmaceuticals:
Congestive Heart Failure
Impaired Renal Function
Study placed in the following topic categories:
Heart Diseases
Furosemide
Heart Failure, Congestive
Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Failure, Congestive
ClinicalTrials.gov processed this record on January 04, 2008 |
