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Sponsored by: |
TransTech Pharma |
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Information provided by: | TransTech Pharma |
ClinicalTrials.gov Identifier: | NCT00119457 |
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
Condition | Intervention | Phase |
---|---|---|
Venous Thromboembolism Embolism and Thrombosis Hip Fractures |
Drug: TTP889 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Weeks Extended VTE Prophylaxis With Daily Oral Doses of TTP889 After One Week of Standard Prophylactic Treatment Following Hip Fracture Surgery |
Estimated Enrollment: | 300 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | April 2006 |
FIXIT is the first Phase 2 study of TTP889. The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE). The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2 | |
Praha 8, Czech Republic, 180 81 | |
Nemocnice Ceske Budejovice, Urazove oddeleni | |
Ceske Budejovice, Czech Republic, 370 87 | |
VFN, I. Chirurgicka klinika | |
Praha-2, Czech Republic, 128 08 | |
FN s Poliklinikou Ostrava, Traumatologicke Centrum | |
Ostrava-Poruba, Czech Republic, 708 52 | |
FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol | |
Praha 5, Czech Republic, 150 06 | |
Denmark | |
Amtsygehuset i Gentofte | |
Hellerup, Denmark, 2900 | |
Silkeborg Hospital | |
Silkeborg, Denmark, 8600 | |
H:S Bispebjerg Hospital | |
Kobenhavn, Denmark, 2400 | |
Horsholm Hospital | |
Horsholm, Denmark, 2970 | |
KAS Herlev | |
Herlev, Denmark, 2730 | |
AAlborg Hospital | |
Aalborg, Denmark, 9000 | |
Ortopaedkirurgisk Klinik, Farso | |
Farso, Denmark, 9640 | |
Norway | |
Halfdan Wilhelmsens Alle 17 | |
Tonsberg, Norway, 3116 | |
Orthopedics, Alesund Sykehus | |
Alesund, Norway, 6026 | |
Skyehuset Innlandet HF | |
Gjovik, Norway, 2819 | |
Skyehuset Innlandet HF | |
Lillehammer, Norway, 2609 | |
Sweden | |
Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus | |
Udevalla, Sweden, 451 80 | |
Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus | |
Kungalv, Sweden, 442 83 | |
Ortoped kliniken, Sahlgrenska Universitetssjukhus | |
Molndal, Sweden, 431 80 | |
Ortoped kliniken, Sjukhuset i Varberg | |
Varberg, Sweden, 432 81 | |
Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra | |
Goteborg, Sweden, 416 85 |
Study Chair: | Bengt I Eriksson, MD | Dept of Orthopaedics, Goteborg University |
Study Director: | David P Ward, MD | TransTech Pharma |
Study ID Numbers: | TTP889-201, Eudract CT#2004-002511-83 |
Study First Received: | July 5, 2005 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00119457 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Czech Republic: State Institute for Drug Control |
antithrombotic agents anticoagulants prophylaxis |
embolism deep vein thrombosis hip fracture |
Hemophilia B Anticoagulants Fractures, Bone Vascular Diseases Wounds and Injuries Disorders of Environmental Origin Fibrinolytic Agents Venous Thromboembolism |
Thrombosis Thromboembolism Hip Fractures Embolism and Thrombosis Femoral Fractures Embolism Leg Injuries Venous Thrombosis |
Fractures, Bone Vascular Diseases Wounds and Injuries Disorders of Environmental Origin Hip Injuries Venous Thromboembolism Thromboembolism |
Thrombosis Hip Fractures Embolism and Thrombosis Femoral Fractures Embolism Leg Injuries Cardiovascular Diseases |