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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00311090
First received: April 4, 2006
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Deep Venous Thrombosis
Drug: Idrabiotaparinux
Drug: Idraparinux
Drug: Avidin
Drug: Placebo (for Avidin)
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: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters [ Time Frame: Day 183 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations [ Time Frame: Days 15, 36, 57, 92 and 183 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC [ Time Frame: First 6 months ] [ Designated as safety issue: No ]

Enrollment: 757
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idrabiotaparinux

Idrabiotaparinux, 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

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, 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

0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Other Names:
  • Idraparinux sodium
  • SR34006
Drug: Placebo (for Avidin)

Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 20 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00311090     History of Changes
Other Study ID Numbers: EFC5945, 2005-005326-30
Study First Received: April 4, 2006
Last Updated: November 27, 2013
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 August 28, 2014