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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2006-000152-41-FI
Date of registration:	17/03/2006
Prospective Registration:	Yes
Primary sponsor:	sanofi-aventis recherche développement
Public title:	A multicenter, Randomized, Double Blind, Double Dummy, Parallel Group, Dose Ranging Study of subcutaneous SR123781A with an Enoxaparin calibrator arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement surgery - DRIVE
Scientific title:	A multicenter, Randomized, Double Blind, Double Dummy, Parallel Group, Dose Ranging Study of subcutaneous SR123781A with an Enoxaparin calibrator arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement surgery - DRIVE
Date of first enrolment:	07/06/2006
Target sample size:	1020
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000152-41
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: no Other: no
Phase:

Countries of recruitment
Czech Republic	Finland	Sweden

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Age = 18 years
Undergoing elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed = 6 months prior to study entry
Written informed consent
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:
Related to study methodology
o Pregnant or nursing women, or women of childbearing potential who are not
using an effective contraceptive method and who do not have a negative
pregnancy test performed immediately before randomization
o Treatment with any investigational product or investigational device in the last
30 days prior to randomization
o Current addictive disorders that could interfere with study participation
o Known progressive malignant disease
o Ischemic stroke, myocardial infarction, any major orthopedic surgeryin the last 3 months
o Clinical signs or symptoms of DVT or PE within the last 12 months or
symptoms of post phlebitic syndrome
o Treatment with other antithrombotic agents within 7 days prior to surgery
o Serum creatinine > 2 mg/dL (180 µmol/L) in a well hydrated patient
o Significant anemia (Hb < 10 g/dL)
o Known sensitivity to iodine or contrast dyes
o Use of any contraindicated drug that cannot be combined with the injection of
contrast medium, e.g. antihyperglycemic drug metformin
Related to the active calibrator
o Any contra-indication or history of hypersensitivity to UFH or LMWH
o Past or present bleeding disorder
o Active or recent (<3 months) significant bleeding, including gastrointestinal
bleeding or peptic ulcer
o Uncontrolled arterial hypertension
o Any history of hemorrhagic stroke
o Known structural damage or other pathologic process involving the central
nervous system
o Recent (<3 months) trauma, major surgery, ophthalmic surgery or parenchymal
organ biopsy
o Thrombocytopenia
o History of heparin induced thrombocytopenia

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

Health Condition(s) or Problem(s) studied

prevention of VTE in patients undergoing elective total hip replacement surgery
MedDRA version: 8.1 Level: LLT Classification code 10049909

Intervention(s)

Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.0-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is a composite of the following VTE outcome events:
• Any DVT identified on mandatory venography of the lower limbs performed between day 5 and day 11
• Confirmed DVT and/or non-fatal PE in case of symptoms earlier than the date of the mandatory venography
• VTE related deaths (Fatal PE and unexplained death) before the mandatory examination

Main Objective: To demonstrate the efficacy of SR123781A in the prevention of Venous Thromboembolism (DVTand/or PE) via demonstration of a dose-response in patients undergoing total hip replacement surgery

Secondary Objective: To evaluate the safety (incidence of major bleeding) of SR123781A in the prevention of VTE after elective total hip replacement surgery
To assess the SR123781 pharmacokinetic profile in patients undergoing elective total hip replacement surgery

Secondary Outcome(s)

Secondary ID(s)

2006-000152-41-SE

DRI5664

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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