Trial Information

Summary: A Study of Torasemide Compared With Furosemide in Patients With Renal Failure or Nephrotic Syndrome

Status: Completed

Protocol Number: ML18113

Sponsor: Shanghai Roche Pharmaceuticals Ltd.

Company Division: Pharmaceutical

Official Scientific Title: An open-label, randomized, multicenter study to assess diuresis and safety of torasemide versus furosemide in the treatment of patients with acute/chronic renal failure or nephrotic syndrome

Brief Summary: This study will compare the diuretic effect and safety of torasemide versus a comparator drug in patients with chronic or acute renal failure or nephrotic syndrome. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 120.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Renal Failure

Intervention Type: Drug

Intervention Name: torasemide[Torem/Unat]

Primary Outcome: 1. Efficacy: effectual diuresis rate. Safety: adverse events, changes in serum electrolytes.

Key Secondary Outcomes: 1. Mean time to effectual diuresis, mean dosage giving effectual diuresis, change in body weight, and change in edema status.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 03/10/2006

Date Last Updated: 08/15/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:21:56 PM