315
Participants
Start Date
October 31, 2012
Primary Completion Date
May 31, 2014
Study Completion Date
August 31, 2014
ISIS-FXIRx Dose #2
Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
ISIS-FXIRx Dose #3
Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
Enoxaparin
Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). \[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\]
Isis Investigational Site, Sofia
Isis Investigational Site, Plovdiv
Isis Investigational Site, Rousse
Isis Investigational Site, Cherkassy
Isis Investigational Site, Kharkiv
Isis Investigational Site, Odesa
Isis Investigational Site, Ivano-Frankivsk
Isis Investigational Site, Sevastopol
Isis Investigational Site, Yaroslavl
Isis Investigational Site, Saint Petersburg
Isis Investigational Site, Saint Petersburg
Isis Investigational Site, Saint Petersburg
Isis Investigational Site, Samara
Isis Investigational Site, Chelyabinsk
Isis Investigational Site, Orenburg
Isis Investigational Site, Ajax
Isis Investigational Site, Oshawa
Isis Investigational Site, Ādaži
Isis Investigational Site, Riga
Isis Investigational Site, Valmiera
Isis Investigational Site, Kyiv
Lead Sponsor
Ionis Pharmaceuticals, Inc.
INDUSTRY