NCT00568009

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	SLV320	1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-12-05
• Last updated: 2008-04-22

Locations

72 sites across 10 countries: United States, Argentina, Belgium, Czechia, Germany, Poland, Russia, Serbia and Montenegro, South Africa, Spain