International, multicenter, randomized, parallel group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E (3.0 mg) once a week and SR34006 (2.5 mg) once a week, documenting the safety and efficacy of both compounds during a 6-month treatment, and demonstrating the neutralizing effect of SSR29261 on the SSR126517E-induced anti-Xa activity. - EQUINOX

• Conditions: Patients with confirmed acute symptomatic DVT of the lower limbs; MedDRA version: 8.1Level: PTClassification code 10051055

• Registration Number: EUCTR2005-005326-30-AT
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Confirmed acute symptomatic DVT of the lower limbs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1-Exclusion criteria before initial randomization:
Legal lower age limitations (country specific).
Creatinine clearance < 30 mL/min.
Severe hepatic disease.
Bacterial endocarditis.
Active bleeding or high risk for bleeding.
Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg.
Pregnancy or childbearing potential without proper contraceptive measures.
Breastfeeding.
Known allergy to idraparinux, SSR126517E, or egg proteins.
-Criteria related to study methodology
Written informed consent not signed.
Indication of prolonged anticoagulation for other reason than DVT of the lower limbs.
Symtomatic pulmonary embolism (PE).
Any administration or intended use of a fibrinolytic agent, thrombectomy, insertion of a caval filter, to treat the current episode of DVT.
More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) Heparin, fondaparinux or initiation of VKA treatment prior to randomization
Life expectancy < 6 months.
Participation in another pharmacotherapeutic study within the prior 30 days.
Impossibility to meet protocol requirements.

2-Exclusion criteria at the end of the 6-month treatment period for participation in the avidin neutralizing effect assessment
Patient receiving open-label avidin during the study.
Patient requiring more than 6-month anticoagulant treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified