NCT00525707

Tezosentan in Acute Heart Failure

Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

Conditions

• Acute Heart Failure
• Acute Decompensation of Chronic Heart Failure
• New Onset of Heart Failure

Interventions

Type	Name	Description
DRUG	tezosentan	tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4ML/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2007-09-06
• Last updated: 2018-07-10

Locations

35 sites across 10 countries: United States, Austria, Denmark, France, Germany, Greece, Israel, Poland, Switzerland, United Kingdom