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
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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 |
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.
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:
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 |
- Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters [ Time Frame: Day 183 ]
- 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 ]
- Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations [ Time Frame: Days 15, 36, 57, 92 and 183 ]
- 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 ]
- Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC [ Time Frame: First 6 months ]

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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.

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
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina | |
Sanofi-Aventis | |
Buenos Aires, Argentina, 1642 | |
Australia | |
Sanofi-Aventis | |
Macquarie Park, Australia, NSW 2113 | |
Austria | |
Sanofi-Aventis | |
Vienna, Austria, 1220 | |
Belgium | |
Sanofi-Aventis | |
Diegem, Belgium, 1831 | |
Brazil | |
Sanofi-Aventis | |
Sao Paulo, Brazil, 05677-000 | |
Canada | |
Sanofi-Aventis | |
Laval, Canada, H7L 4A8 | |
Czech Republic | |
Sanofi-Aventis | |
Praha, Czech Republic, 160 00 | |
Denmark | |
Sanofi-Aventis | |
Copenhagen, Denmark | |
France | |
sanofi-aventis France | |
Paris, France | |
Israel | |
sanofi-aventis Israel | |
Natanya, Israel | |
Italy | |
Sanofi-aventis | |
Milan, Italy | |
Mexico | |
sanofi-aventis Mexico | |
Mexico, Mexico | |
Netherlands | |
sanofi-aventis, Netherlands | |
Gouda, Netherlands | |
New Zealand | |
Sanofi-Aventis | |
New Zealand, New Zealand | |
Poland | |
Sanofi-Aventis | |
Warsawa, Poland, 02-672 | |
Russian Federation | |
Sanofi-aventis | |
Moscow, Russian Federation, 103045 | |
South Africa | |
Sanofi-Aventis | |
Midrand, South Africa, 1685 | |
Spain | |
Sanofi-Aventis | |
Barcelona, Spain, 08019 | |
Turkey | |
sanofi-aventis Turkey | |
Istanbul, Turkey |
Study Director: | ICD CSD | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Deep Venous Thrombosis |
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Idraparinux Idrabiotaparinux |
Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |