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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

Further study details as provided by Sanofi:

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.

Enrollment:	757
Study Start Date:	March 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Investigators

Study Director:

ICD CSD

Sanofi

More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00311090 History of Changes
Other Study ID Numbers:	EFC5945, SSR126517E,, biotinylated idraparinux
Study First Received:	April 4, 2006
Last Updated:	February 12, 2010
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:

Deep Venous Thrombosis

Additional relevant MeSH terms:

Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on May 16, 2013