CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 541 enrolled
Drug / intervention
innohep® +1 moredrug
Likely dose
Heparin 50 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00277394
NCT00277394Phase 4Completed
CompareCT.gov

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

LEO Pharma·interventional·Posted Jan 16, 2006·Updated Mar 6, 2025

In Brief

A Phase 4 clinical trial evaluating innohep® and Heparin for Deep Vein Thrombosis. Completed, enrolled 541 participants across 9 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Vein Thrombosis
CountriesBulgaria, Croatia, Czechia, France, Germany, Poland, Romania, Serbia, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2006
Enrollment StartDec 1, 2005
Primary CompletionMay 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.5 years ago

Interventions

innohep®drug

175 anti-Xa IU/kg administered subcutaneously (SC) once daily

Heparindrug

Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.