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 - EQUINOX

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005326-30-IT
• Date of registration: 12/10/2006
• Prospective Registration: No
• Primary sponsor: Sanofi-Synthelabo Recherche
• Public 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 - EQUINOX
• Scientific 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 - EQUINOX
• Date of first enrolment: 28/04/2006
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005326-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Austria, Czech Republic, Denmark, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Confirmed acute symptomatic DVT of the lower limbs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1-Exclusion criteria before initial randomization Legal lower age limitations country specific . Creatinine clearance 30 mL/min. Severe hepatic disease. Bacterial endocarditis. Active bleeding or high risk for bleeding. Uncontrolled hypertension systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg. Pregnancy or childbearing potential without proper contraceptive measures. Breastfeeding. Known allergy to idraparinux, SSR126517E, or egg proteins. -Criteria related to study methodology Written informed consent not signed. Indication of prolonged anticoagulation for other reason than DVT of the lower limbs. Symtomatic pulmonary embolism PE . Any administration or intended use of a fibrinolytic agent, thrombectomy, insertion of a caval filter, to treat the current episode of DVT. More than 36 hours pre-randomization treatment with therapeutic dosages of LMW Heparin, fondaparinux or initiation of VKA treatment prior to randomization Life expectancy 6 months. Participation in another pharmacotherapeutic study within the prior 30 days. Impossibility to meet protocol requirements. 2-Exclusion criteria at the end of the 6-month treatment period for participation in the avidin neutralizing effect assessment Patient receiving open-label avidin during the study. Patient requiring more than 6-month anticoagulant treatment


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with confirmed acute symptomatic DVT of the lower limbs
MedDRA version: 8.1 Level: LLT Classification code 10051055 Term: Deep vein thrombosis

Intervention(s)

Product Name: IDRAPARINUX
Product Code: SR34006
Pharmaceutical Form: Solution for injection
CAS Number: 149920-56-9
Current Sponsor code: SR34006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: AVIDIN
Product Code: SR29261
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 1405-69-2
Current Sponsor code: SSR29261
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: BIOTINYLATED IDRAPARINUX
Product Code: SSR126517E
Pharmaceutical Form: Solution for injection
CAS Number: 405159-59-3
Current Sponsor code: SSR126517
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Primary end point(s): 1-Bioequipotency assessment, avidin neutralizing effect assessment and time course to steady state achievement The PD variable is the anti-Xa activity, measured without excess of antithrombin AT , relative to the maximal effect in a pool of plasma from healthy volunteers. The PK variable is the anti-Xa activity, measured with excess of AT. 2-Safety assessment The main two-safety outcome events are bleeding, reported as either AE or SAE, and validated by the CIAC, and death cause of death validated by the CIAC . 3-Efficacy assessment The main efficacy outcome is symptomatic recurrent DVT/PE fatal or not , as validated by the CIAC.

Secondary Objective: To assess the time course to steady state achievement of SSR126517E/SR34006. To provide safety and efficacy data on biotinylated idraparinux SSR126517E compared to idraparinux SR34006

Main Objective: Primary objective of the bioequipotency assessment To demonstrate the bioequipotency of biotinylated idraparinux SSR126517E and idraparinux SR34006 at steady state, in patients, with acute symptomatic DVT, as assessed by anti-Xa activity. -Primary objective of the avidin neutralizing effect assessment To demonstrate the neutralizing effect of avidin SSR29261 on anti-Xa activity induced by biotinylated idraparinux SSR126517E

Secondary ID(s)

2005-005326-30-AT

EFC5945