Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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:
- adult patients 18-70 years of age;
- acute or chronic renal failure or nephrotic syndrome
Exclusion criteria:
- hypotension (systolic blood pressure <100 mmHg);
- hemodialysis;
- end-stage renal failure;
- acute diabetic metabolic disorders.
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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Guangzhou
- Shanghai
