Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

NCT ID: NCT00714597

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

Brief Summary

The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Detailed Description

Randomization had to take place just prior to the first study drug injection.

The total duration of observation per participant was 35-42 days from randomization broken down as follows:

• 10 to 14-day double-blind treatment period;
• 25 to 32-day follow-up period.

Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Semuloparin

Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 10-14 days

Group Type: EXPERIMENTAL

Semuloparin sodium

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Enoxaparin

Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 10-14 days

Group Type: ACTIVE_COMPARATOR

Enoxaparin sodium

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Interventions

Semuloparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Intervention Type: DRUG

Enoxaparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

AVE5026; Lovenox®

Eligibility Criteria

Inclusion Criteria

Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:

• Congestive heart failure (New York Heart Association [NYHA] class III/IV);
• Acute respiratory failure (not requiring mechanical ventilation);
• Acute infection (without septic shock)*;
• Acute rheumatic disorder*;
• Acute episode of inflammatory bowel disease*.

• Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:

• Age ≥ 75 years;
• Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
• Previous VTE;
• Obesity;
• Oral hormone therapy (antiandrogen or estrogen);
• Chronic heart failure;
• Chronic respiratory failure.

Exclusion Criteria

• Previous surgery with general anesthesia within 30 days before inclusion in the study;
• Patient requiring a curative anticoagulant or thrombolytic treatment;
• Patient at risk of bleeding;
• Stroke;
• Known hypersensitivity to heparin or enoxaparin sodium;
• End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Mismetti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Saint-Etienne, France

Alexander Turpie, MD

Role: STUDY_CHAIR

HHS-General Hospital, Hamilton, Canada

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Vienna, , Austria

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Prague, , Czechia

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Berlin, , Germany

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

Riga, , Latvia

Sanofi-Aventis Administrative Office

Vilnius, , Lithuania

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Sanofi-Aventis Administrative Office

Auckland, , New Zealand

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Sanofi-Aventis Administrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Kiev, , Ukraine

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Countries

United States; Australia; Austria; Canada; Czechia; Estonia; France; Germany; Hungary; India; Italy; Latvia; Lithuania; Mexico; Netherlands; New Zealand; Romania; Russia; South Korea; Spain; Ukraine; United Kingdom

Other Identifiers

2008-000228-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10572

Identifier Type: -

Identifier Source: org_study_id