NCT00277394

Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	innohep®	175 anti-Xa IU/kg administered subcutaneously (SC) once daily
DRUG	Heparin	Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2006-01-16
• Last updated: 2025-03-06
• Results posted: 2010-12-21

Locations

9 sites across 9 countries: Bulgaria, Croatia, Czechia, France, Germany, Poland, Romania, Serbia, Spain