MedTrace Logo

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

NCT00277394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2025-03-06

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Alain Leizorovicz, MD · Faculté de Médecine Laënnec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-05-31
Completion
2008-07-31

Countries

  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Poland
  • Romania
  • Serbia
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277394 on ClinicalTrials.gov