Bioequipotency Study of SSR126517E and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs (EQUINOX) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00311090

Purpose

The three purposes of this study are the following:

To compare during a 6-month treatment the safety and effectiveness of biotinylated idraparinux (SSR126517E) with that of idraparinux, taking into account new events of deep venous thrombosis and pulmonary embolism, and bleeding risk;
To compare the activities of biotinylated idraparinux (SSR126517E) and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of biotinylated idraparinux at the end of a 6-month treatment period.

Condition	Intervention	Phase
Deep Venous Thrombosis	Drug: SSR126517E, idraparinux, SSR29261	Phase III

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: SR 34006

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Bioequipotency Study of SSR126517E and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs and Study of the Neutralizing Effect of SSR29261 on the SSR126517E-Induced Anti-Xa Activity

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Bioequipotency assessment and avidin neutralizing effect assessment, at steady state:
The pharmacodynamic/pharmacokinetic variable is the antithrombotic activity (anti-Xa activity)

Secondary Outcome Measures:

PK/PD: time course to steady state achievement(anti-Xa activity)
Safety:bleeding adverse events and deaths within 6 months validated by the Central Independent Adjudication Committee (CIAC).
Efficacy:symptomatic recurrent DVT/PE (fatal or not) within 6 months validated by the CIAC.

Estimated Enrollment:	700
Study Start Date:	March 2006

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension)
Active bleeding or high risk for bleeding.
Pregnancy or childbearing potential without proper contraceptive measures.
Breastfeeding
Known allergy to idraparinux, SSR126517E, or egg proteins
Indication of prolonged anticoagulation for other reason than DVT of the lower limbs
Symptomatic pulmonary embolism (PE)
Life expectancy < 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311090

Sponsors and Collaborators

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5945, SSR126517E,, biotinylated idraparinux
Study First Received:	April 4, 2006
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00311090 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; South Africa: Medicines Control Council; Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Sanofi-Aventis:

Deep Venous Thrombosis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Heparin, Low-Molecular-Weight

Vascular Diseases
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on May 07, 2009