Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-006896-19-SE
EUCTR2006-006896-19-SEActive, not recruitingNot Applicable

A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery. Revised Protocol 02: Incorporating Protocol Amendment 02 (v2.0, date 18-Apr-2007) and Protocol Amendment 04 (v2.0, date 05-May-2008).And Pharmacogenetics Blood Sample Amendment 01 (v2.0, date 31-Jan-2007)And Revised Protocol 03 incorporating protocol Amendment 05 (v1.0 dated 31-Oct-2008 and Admin letter 02 (v2.0 dated 12-Jun-2008) - The ADVANCE - 2 Study

Bristol Myers Squibb International Corporation0 sites3,670 target enrollmentStarted: August 6, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
3,670
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1) Subjects must be willing and able to give written informed consent. Consent to
  • •participate in the study must be obtained prior to any screening procedures.
  • •2) Subjects undergoing elective unilateral or bilateral same day total knee replacement or a revision of at least one component of a total knee replacement.
  • •3) Subject must be willing and able to undergo bilateral ascending contrast
  • •venography.
  • •4) Men and women, of any race, at least 18 (or legal age of consent if greater) years of age
  • •5) Women of childbearing potential (WOCBP) must be using an adequate method of
  • •contraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
  • •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) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire treatment period of the study
  • •2) Women who are pregnant or breastfeeding
  • •3) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration
  • •4) Known or suspected or acquired bleeding or coagulation disorder in the subject or a first degree relative
  • •5) Known or suspected history of heparin-induced thrombocytopenia
  • •6) Known coagulopathy
  • •7) Active bleeding or at high risk for bleeding
  • •8) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
  • •9) Active hepatobiliary disease
  • •10) Alcohol and/or substance abuse within the past year
  • •11) Any condition, in the opinion of the Investigator, for which surgery or
  • •administration of an anticoagulant is contraindicated
  • •12) Two consecutive blood pressure readings within 15-30 minutes with supine
  • •SBP > 180 mm Hg or supine DBP > 105 mm Hg
  • •13) Hemoglobin < 10 g/dL
  • •14) Platelet count < 100,000/mm3
  • •15) Creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and
  • •Gault (see Section 6.3.4)
  • •16) ALT or AST > 2 x ULN or a Total Bilirubin = 1.5 x ULN (unless an alternative
  • •causative factor [eg, Gilbert’s syndrome] is identified)
  • •17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin
  • •(LMWH), porcine products, or iodinated contrast medium (for venogram)
  • •18) Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
  • •19) Current use of dextrans or fibrinolytics (but the use of synthetic colloids like
  • •pentastarch and hetastarch as blood substitutes is allowed)
  • •20) Treatment with medications affecting coagulation or platelet function as follows:
  • •Unfractionated heparin, LMWH, warfarin (or any other VKA), glycoprotein
  • •IIb/IIIa inhibitors (eg, abciximab, eptifibatide, tirofiban) within 4 days before
  • •Acetylsalicylic acid > 165 mg/day within 4 days before surgery
  • •Clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone within 7 days before
  • •Non-selective NSAIDs with a T1/2 greater than 17 hours (eg, Piroxicam and
  • •Tinoxican) within 7 days before surgery
  • •Fondaparinux within 7 days before surgery
  • •Anti-fibrinolytics, with exception of the use of tranexamic acid where it
  • •represents standard of care for the investigator
  • •21) Planned indwelling intrathecal or epidural catheter that can not be removed at least 5 hours prior to first dose of post-operative study drug.
  • •22) Prisoners or subjects who are involuntarily incarcerated.
  • •23) Subjects who are compulsorily detained for treatment of either a psychiatric or
  • •physical (eg, infectious disease) illness.
  • •24) Subjects who have been previously randomized into an apixaban clinical trial.
  • •25) Administration of any investigational drug currently or within 30 days prior to
  • •enrollment into this study.
  • •26) Any other contra-indication listed in the country specific labeling for enoxaparin.

Investigators

Similar Trials

Active, not recruiting
Not Applicable
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery.And Pharmacogenetics Blood Sample Amendment 01 (Version 2.0, Date 31-Jan-2007)Revised Protocol 02: Incorporating Protocol Amendment 02 (v2.0, dated 18-Apr-2007) and Protocol Amendment 04 (v2.0, dated 05-May-2008).Revised Protocol 03: Incorporating Protocol Amendment 05 ( v1.0 dated 31-Oct-2008) and Admin Letter 02 (dated 12-Jun-2008) - The ADVANCE - 2 Study
EUCTR2006-006896-19-BEBristol Myers Squibb International Corporation3,670
Active, not recruiting
Phase 1
A clinical trial in patients with poorly controlled type 2 diabetes to compare the effectiveness of bexagliflozin with glimepirideDiabetes Mellitus Type 2MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
EUCTR2016-002013-21-PLTheracos Sub, LLC701
Active, not recruiting
Not Applicable
A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery+ Pharmacogenetics Blood Sample Amendment 01 (Version 1.0 - dated 27-Nov-2006)Revised Protocol 01, incorporating Protocol amendment 02 and Admin Letter 01 (Version 3.0, dated 21-Jun-07)Protocol Amendment 03 (Version 1.0 - dated 29-Apr-08)
EUCTR2006-005351-14-HUBristol-Myers Squibb International Corporation5,947
Active, not recruiting
Phase 1
A Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults with Complicated Urinary Tract Infections.
EUCTR2018-001451-13-HUVenatoRx Pharmaceuticals, Inc.582
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery.+ Revised Protocol 01: Incorporates Amendment 02 dated 18-Apr-2007 - The ADVANCE - 2 Study
EUCTR2006-006896-19-FRBristol Myers Squibb International Corporation3,670