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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-006202-26 | EudraCT Number |
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The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee replacement [TKR] surgery.
Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.
The randomization had to take place before the first study drug injection.
The total duration of observation per participant was 27-33 days from surgery broken down as follows:
Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semuloparin 5 mg | Experimental | Semuloparin sodium 5 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Semuloparin 10 mg | Experimental | Semuloparin sodium 10 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Semuloparin 20 mg | Experimental | Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Semuloparin 40 mg | Experimental | Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Semuloparin 60 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semuloparin sodium | Drug | 0.8 mL solution in Type I amber glass vials Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death | VTE included any Deep Vein Thrombosis [DVT] identified on mandatory venography of the lower limbs; symptomatic DVT and/or non-fatal pulmonary embolism [PE] before mandatory examination; VTE related deaths included fatal PE or deaths which could not be attributed to a documented cause and for which PE could not be ruled out. All events were to be confirmed by a Central Independent Adjudication Committee [CIAC] based on venographies, scheduled or unscheduled, and other available diagnostic tests (ultrasonography, ventilation/perfusion lung scan, pulmonary angiography, autopsy report, etc). | From surgery to Day 11 or the day of mandatory venography, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced DVT | From surgery up to Day 11 or the day of mandatory venography, whichever came first | |
| Number of Participants Who Experienced Symptomatic VTE | Symptomatic VTE included:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths | All deaths were centrally and blindly reviewed by the CIAC and classified as "Fatal PE", "PE not excluded", "Fatal bleeding" and "Death not associated with VTE or bleeding" based on relevant documentation (e.g. autopsy report). | From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Michael LASSEN, MD | Hoersholm Hospital (Denmark) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Buenos Aires | Argentina | ||||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19187076 | Result | Lassen MR, Dahl OE, Mismetti P, Destree D, Turpie AG. AVE5026, a new hemisynthetic ultra-low-molecular-weight heparin for the prevention of venous thromboembolism in patients after total knee replacement surgery--TREK: a dose-ranging study. J Thromb Haemost. 2009 Apr;7(4):566-72. doi: 10.1111/j.1538-7836.2009.03301.x. Epub 2009 Jan 24. |
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| Experimental |
Semuloparin sodium 60 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Enoxaparin 40 mg | Active Comparator | Enoxaparin sodium 40 mg + Placebo (for Semuloparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
|
| Placebo pre-op / Semuloparin 20 mg | Experimental | Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery |
|
| Placebo pre-op / Semuloparin 40 mg | Experimental | Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery |
|
|
| Placebo (for Enoxaparin sodium) | Drug | 0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection |
|
| Enoxaparin sodium | Drug | 0.4 mL solution in ready-to-use pre-filled syringe Subcutaneous injection |
|
|
| Placebo (for Semuloparin sodium) | Drug | 0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component Subcutaneous injection |
|
| From surgery up to Day 11 or the day of mandatory venography, whichever came first |
| Number of Participants Who Experienced Bleedings | Bleedings were centrally and blindly reviewed by the CIAC and classified as:
| From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) |
| Number of Participants Who Required Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment | Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answers to questions asked after diagnostic tests for suspected VTE and/or the mandatory venography. | From surgery up to Day 11 or the day of mandatory venography, whichever came first |
| Platelets Count: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Threshold for platelet counts was defined as <100 Giga/L. | From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) |
| Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | Thresholds were defined as follows:
| From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) |
| Sofia |
| Bulgaria |
| Sanofi-Aventis Administrative Office | Santiago | Chile |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-Aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Athens | Greece |
| Sanofi-Aventis Administrative Office | Kuala Lumpur | Malaysia |
| Sanofi-Aventis Administrative Office | México | Mexico |
| Sanofi-Aventis Administrative Office | Lysaker | Norway |
| Sanofi-Aventis Administrative Office | Makati City | Philippines |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Taipei | Taiwan |
| Sanofi-Aventis Administrative Office | Bangkok | Thailand |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C542814 | AVE 5026 |
| C000711671 | enoxaparin sodium |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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