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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00311090




Registration number
NCT00311090
Ethics application status
Date submitted
4/04/2006
Date registered
5/04/2006
Date last updated
21/03/2016

Titles & IDs
Public title
Bioequipotency Study of Idrabiotaparinux and Idraparinux in Patients With Deep Venous Thrombosis of the Lower Limbs
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
Secondary ID [1] 0 0
2005-005326-30
Secondary ID [2] 0 0
EFC5945
Universal Trial Number (UTN)
Trial acronym
EQUINOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idrabiotaparinux sodium
Treatment: Drugs - Idraparinux sodium
Treatment: Drugs - Avidin
Treatment: Drugs - Placebo (for Avidin)

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)

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)


Treatment: Drugs: Idrabiotaparinux sodium
0.5 mL pre-filled syringe for 3.0 mg

Subcutaneous injection

Treatment: Drugs: Idraparinux sodium
0.5 mL pre-filled syringe for 2.5 mg

Subcutaneous injection

Treatment: Drugs: Avidin
100 mg in 10 mg/mL solution

Intravenous infusion for 30 minutes

Treatment: Drugs: Placebo (for Avidin)
Avidin matching powder in 10 mg/mL solution

Intravenous infusion for 30 minutes
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters
Timepoint [1] 0 0
Day 183
Primary outcome [2] 0 0
Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion
Timepoint [2] 0 0
Day 183 to Day 188
Secondary outcome [1] 0 0
Pharmacokinetic profile: idrabiotaparinux and idraparinux plasma concentrations
Timepoint [1] 0 0
Days 15, 36, 57, 92 and 183
Secondary outcome [2] 0 0
Safety: number of participants with clinically relevant bleedings and number of deaths as confirmed by a Central Independent Adjudication Committee (CIAC)
Timepoint [2] 0 0
First 6 months
Secondary outcome [3] 0 0
Efficacy: number of participants with symptomatic recurrent venous thromboembolism as confirmed by the CIAC
Timepoint [3] 0 0
First 6 months

Eligibility
Key inclusion criteria
* Confirmed acute symptomatic DVT of the lower limbs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
757
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
NSW 2113 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Israel
State/province [10] 0 0
Natanya
Country [11] 0 0
Italy
State/province [11] 0 0
Milan
Country [12] 0 0
Mexico
State/province [12] 0 0
Mexico
Country [13] 0 0
Netherlands
State/province [13] 0 0
Gouda
Country [14] 0 0
New Zealand
State/province [14] 0 0
New Zealand
Country [15] 0 0
Poland
State/province [15] 0 0
Warsawa
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
South Africa
State/province [17] 0 0
Midrand
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Equinox Investigators. Efficacy and safety of once... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00311090