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Trial record 3 of 6 for:    EQUINOX

Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs (EQUINOX)

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ClinicalTrials.gov Identifier: NCT00311090
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):

Brief Summary:

The three purposes of this study are the following:

  • To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
  • To compare the activities of idrabiotaparinux 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 idrabiotaparinux at the end of a 6-month treatment period.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Drug: Idrabiotaparinux sodium Drug: Idraparinux sodium Drug: Avidin Drug: Placebo (for Avidin) Phase 3

Detailed Description:

The study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12.

All participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 757 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: Idrabiotaparinux

Idrabiotaparinux sodium , 3.0 mg, once-weekly for 6 months.

In avidin sub-study, participants receive on Day 183, avidin 100 mg or placebo (for avidin) (4 hours after Idrabiotaparinux administration)

Drug: Idrabiotaparinux sodium

0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Other Names:
  • Biotinylated Idraparinux
  • SSR126517

Drug: Avidin

100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Other Name: SSR29261

Drug: Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Active Comparator: Idraparinux

Idraparinux sodium, 2.5 mg, once-weekly for 6 months

In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration)

Drug: Idraparinux sodium

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Other Name: SR34006

Drug: Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes

Primary Outcome Measures :
  1. Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters [ Time Frame: Day 183 ]
  2. Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion [ Time Frame: Day 183 to Day 188 ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations [ Time Frame: Days 15, 36, 57, 92 and 183 ]
  2. Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC) [ Time Frame: First 6 months ]
  3. Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC [ Time Frame: First 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed acute symptomatic DVT of the lower limbs

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311090

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Buenos Aires, Argentina, 1642
Macquarie Park, Australia, NSW 2113
Vienna, Austria, 1220
Diegem, Belgium, 1831
Sao Paulo, Brazil, 05677-000
Laval, Canada, H7L 4A8
Czech Republic
Praha, Czech Republic, 160 00
Copenhagen, Denmark
sanofi-aventis France
Paris, France
sanofi-aventis Israel
Natanya, Israel
Milan, Italy
sanofi-aventis Mexico
Mexico, Mexico
sanofi-aventis, Netherlands
Gouda, Netherlands
New Zealand
New Zealand, New Zealand
Warsawa, Poland, 02-672
Russian Federation
Moscow, Russian Federation, 103045
South Africa
Midrand, South Africa, 1685
Barcelona, Spain, 08019
sanofi-aventis Turkey
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00311090    
Other Study ID Numbers: EFC5945
2005-005326-30 ( EudraCT Number )
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: February 2016
Keywords provided by Sanofi:
Deep Venous Thrombosis
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action