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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:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-000152-41-CZ |
Date of registration:
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19/04/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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12/05/2006 |
Target sample size:
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1020 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000152-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Czech Republic
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Finland
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Sweden
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Key inclusion & exclusion criteria
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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:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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prevention of VTE in patients undergoing elective total hip replacement surgery MedDRA version: 8.1
Level: LLT
Classification code 10049909
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Intervention(s)
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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
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Primary Outcome(s)
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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
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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
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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
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Secondary ID(s)
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DRI5664
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2006-000152-41-SE
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Source(s) of Monetary Support
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Results
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Results available:
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