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Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odiparcil | Drug | |||
| Warfarin | Drug | |||
| Coumadin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment | Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment. | Up to Visit 7 (10 ± 2 days of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment | Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions 'Left proximal' and 'Right proximal' was 'DVT'. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
A total of 958 participants were randomized into the study. Two participants each from the treatment arm Odiparcil 250 milligram (mg), and Odiparcil 375 mg did not receive the study medication. Therefore, the intent to treat (ITT) population was comprised of 954 participants.
Male or female participants >=35 years of age with scheduled for primary elective unilateral total knee arthroplasty were recruited at 82 centers from 13 countries. The study was conducted between 28 September 2005 and 27 September 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Odiparcil MR 250 mg Tablet | Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period. |
| FG001 | Odiparcil MR 375 mg Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 12 days |
| Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment | A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. | Up to 12 days |
| Percentage of Participants With PE Over 10 ± 2 Days of Treatment | Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question 'Was a PE identified?' was 'Yes'. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days. | Up to 12 days |
| Number of Death Due to VTE Over 10 ± 2 Days of Treatment | A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as 'Fatal PE'. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator's death classification was recorded as 'Fatal PE'. Number of death due to VTE over 10 ± 2 days of treatment were reported. | Up to 12 days |
| Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment | A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. | Up to 12 days |
| Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment | A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported. | Up to 12 days |
| Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up | In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported. | Up to 68 days |
| Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment | A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria. | Up to 12 days |
| Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment | A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported. | Up to 12 days |
| Percentage of Participants With Total VTE Any Time After Start of Treatment | Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported. | Up to Visit 9 (Day 28 post treatment) |
| Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment | The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported. | Up to 12 days |
| Mobile |
| Alabama |
| 36608 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85023 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Banning | California | 92220 | United States |
| GSK Investigational Site | Sacramento | California | 95817 | United States |
| GSK Investigational Site | Torrance | California | 90509 | United States |
| GSK Investigational Site | Yuba City | California | 95991 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Lonetree | Colorado | 80124 | United States |
| GSK Investigational Site | Clearwater | Florida | 33756 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | Sarsota | Florida | 34239 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Boise | Idaho | 83702 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21209 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21215-5271 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21218 | United States |
| GSK Investigational Site | Warren | Michigan | 48089 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Durham | North Carolina | 27704 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45242 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| GSK Investigational Site | Altoona | Pennsylvania | 16601 | United States |
| GSK Investigational Site | Camp Hill | Pennsylvania | 17011 | United States |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Lubbock | Texas | 79410 | United States |
| GSK Investigational Site | San Antonio | Texas | 78217 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Huntington | West Virginia | 25701 | United States |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | United States |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | Southport | Queensland | 4215 | Australia |
| GSK Investigational Site | Box Hill | Victoria | 3128 | Australia |
| GSK Investigational Site | Clayton | Victoria | 3168 | Australia |
| GSK Investigational Site | Geelong | Victoria | 3220 | Australia |
| GSK Investigational Site | Ringwood East | Victoria | 3135 | Australia |
| GSK Investigational Site | Windsor | Victoria | 3181 | Australia |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| GSK Investigational Site | Winnipeg | Manitoba | R3J 3M7 | Canada |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Don Mills | Ontario | M3C 1W3 | Canada |
| GSK Investigational Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| GSK Investigational Site | North York | Ontario | M3M 2G2 | Canada |
| GSK Investigational Site | Oshawa | Ontario | L1G 2B9 | Canada |
| GSK Investigational Site | Scarborough Village | Ontario | M1W 3W3 | Canada |
| GSK Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| GSK Investigational Site | Charlottetown | Prince Edward Island | C1A 1L2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| GSK Investigational Site | Québec | Quebec | G1J 1Z4 | Canada |
| GSK Investigational Site | Sainte Jerome | Quebec | J7Z 5T3 | Canada |
| GSK Investigational Site | Chennai | 600 040 | India |
| GSK Investigational Site | Secunderabad | 500 003 | India |
| GSK Investigational Site | Haifa | 31096 | Israel |
| GSK Investigational Site | Kfar Saba | 44281 | Israel |
| GSK Investigational Site | Petah Tikva | 49372 | Israel |
| GSK Investigational Site | Tel Aviv | 64239 | Israel |
| GSK Investigational Site | Riga | LV1004 | Latvia |
| GSK Investigational Site | Riga | LV1005 | Latvia |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Klaipėda | LT-92288 | Lithuania |
| GSK Investigational Site | Vilnius | LT-04128 | Lithuania |
| GSK Investigational Site | Bialystok | 15-276 | Poland |
| GSK Investigational Site | Krakow | 31-862 | Poland |
| GSK Investigational Site | Sosnowiec | 41-200 | Poland |
| GSK Investigational Site | Wroclaw | 50-043 | Poland |
| GSK Investigational Site | Irkutsk | 664003 | Russia |
| GSK Investigational Site | Kurgan | 640014 | Russia |
| GSK Investigational Site | Moscow | 117415 | Russia |
| GSK Investigational Site | Mosocow | 115516 | Russia |
| GSK Investigational Site | Mosocow | 117593 | Russia |
| GSK Investigational Site | Rostov-on-Don | 344718 | Russia |
| GSK Investigational Site | Pretoria | Gauteng | 0084 | South Africa |
| GSK Investigational Site | Centurion | 157 | South Africa |
| GSK Investigational Site | Pretoria | South Africa |
| GSK Investigational Site | Cherkasy | 18009 | Ukraine |
| GSK Investigational Site | Dnipro | 49005 | Ukraine |
| GSK Investigational Site | Kyiv | 03103 | Ukraine |
| GSK Investigational Site | Kyiv | 04107 | Ukraine |
| GSK Investigational Site | Vinnitsa | 21032 | Ukraine |
| GSK Investigational Site | Birmingham | West Midlands | B18 7QH | United Kingdom |
| GSK Investigational Site | Bournmouth | BH7 7DW | United Kingdom |
| GSK Investigational Site | Fife | KY2 5AH | United Kingdom |
| GSK Investigational Site | London | SE5 9JP | United Kingdom |
| GSK Investigational Site | Wigan | WN6 9EP | United Kingdom |
Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| FG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| FG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Odiparcil MR 250 mg Tablet | Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| BG001 | Odiparcil MR 375 mg Tablet | Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| BG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| BG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment | Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment. | ITT population comprised of all participants who were randomized and received at least one dose of study treatment. Total number of participants with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at study completion were used for analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Visit 7 (10 ± 2 days of treatment) |
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| Secondary | Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment | Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions 'Left proximal' and 'Right proximal' was 'DVT'. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
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| Secondary | Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment | A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | 95% Confidence Interval | Percentage of paticipants | Up to 12 days |
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| Secondary | Percentage of Participants With PE Over 10 ± 2 Days of Treatment | Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question 'Was a PE identified?' was 'Yes'. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
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| Secondary | Number of Death Due to VTE Over 10 ± 2 Days of Treatment | A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as 'Fatal PE'. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator's death classification was recorded as 'Fatal PE'. Number of death due to VTE over 10 ± 2 days of treatment were reported. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | Participants | Up to 12 days |
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| Secondary | Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment | A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
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| Secondary | Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment | A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis. | Posted | Number | 95% Confidence Interval | Perentage of participants | Up to 12 days |
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| Secondary | Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up | In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported. | ITT population. | Posted | Geometric Mean | Standard Deviation | Microgram per millilitre (mcg/ml) | Up to 68 days |
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| Secondary | Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment | A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria. | ITT Population. The participants from ITT population who completed study treatment (Day-10 visit) or reported a major bleed by the time of early withdrawal were used for the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment | A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported. | ITT population. The participants from ITT population who were efficacy evaluable or reported a major bleed or VTE by the time of early withdrawal were used for the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
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| Secondary | Percentage of Participants With Total VTE Any Time After Start of Treatment | Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported. | ITT population. The participants from ITT population who were with objectively confirmed symptomatic VTE, venographically detected VTE at early withdrawal or an evaluable venogram at completion of study treatment were used for the analysis | Posted | Number | 95% Confidence Interval | Percenatge of participants | Up to Visit 9 (Day 28 post treatment) |
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| Secondary | Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment | The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported. | ITT population. Number of participants were available at the time of analysis were included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 12 days |
|
Serious adverse events (SAE) and non-serious adverse events (nSAEs) were collected up to follow-up visit (Visit 9, Day 28±2 days after study medication discontinuation). On-treatment nSAEs were reported.
ITT population was used for analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ODIPARCIL MR 250 mg Tablet | Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. | 14 | 235 | 124 | 235 | ||
| EG001 | ODIPARCIL MR 375 MG TABLET | Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. | 11 | 243 | 120 | 243 | ||
| EG002 | ODIPARCIL MR 500 MG TABLET | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. | 16 | 239 | 122 | 239 | ||
| EG003 | WARFARIN INR 2.0 TO 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. | 9 | 237 | 104 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Bleeding time abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment | General disorders and administration site conditions |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment | General disorders and administration site conditions |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D001281 | Atrial Fibrillation |
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| C514804 | odiparcil |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| Risk Ratio (RR) |
| 1.42 |
| 2-Sided |
| 95 |
| 1.1 |
| 1.9 |
| Superiority or Other |
| Fisher Exact | 0.080 | Risk Ratio (RR) | 1.32 | 2-Sided | 95 | 1.0 | 1.8 | Superiority or Other |
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG002 | Odiparcil MR 500 mg Tablet | Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period. |
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|
| OG003 | Warfarin INR 2.0 to 3.0 | Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period. |
|
|