Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fondaparinux | Experimental |
| |
| unfractionated heparin | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux sodium | Drug | The dose of Fondaparinux will be determined based on a subject's body weight (< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) | VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). | From Day 1 to Day 90 (±7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type) | VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE. | From Day 1 to Day 90 (±7 days) |
| Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 440-8510 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21512258 | Background | Nakamura M, Okano Y, Minamiguchi H, Munemasa M, Sonoda M, Yamada N, Hanzawa K, Aoyagi N, Tsujimoto H, Sarai N, Nakajima H, Kunieda T. Multidetector-row computed tomography-based clinical assessment of fondaparinux for treatment of acute pulmonary embolism and acute deep vein thrombosis in Japanese patients. Circ J. 2011;75(6):1424-32. doi: 10.1253/circj.cj-10-1036. Epub 2011 Apr 22. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111436 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fondaparinux Sodium (FPX) | The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| unfractionated heparin (UFH) | Drug | UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control. |
|
Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE. |
| Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day) |
| Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10 | Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). | Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day) |
| Percentage of Participants With a Bleeding Event | Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). | Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min). |
| Fukuoka |
| 802-8555 |
| Japan |
| GSK Investigational Site | Gunma | 370-0829 | Japan |
| GSK Investigational Site | Gunma | 371-8511 | Japan |
| GSK Investigational Site | Hiroshima | 720-8520 | Japan |
| GSK Investigational Site | Hiroshima | 739-0651 | Japan |
| GSK Investigational Site | Hokkaido | 006-8555 | Japan |
| GSK Investigational Site | Hokkaido | 060-8543 | Japan |
| GSK Investigational Site | Hokkaido | 060-8648 | Japan |
| GSK Investigational Site | Hyōgo | 654-0155 | Japan |
| GSK Investigational Site | Ibaraki | 305-8576 | Japan |
| GSK Investigational Site | Ibaraki | 311-3193 | Japan |
| GSK Investigational Site | Kagoshima | 892-0853 | Japan |
| GSK Investigational Site | Kanagawa | 245-8575 | Japan |
| GSK Investigational Site | Kumamoto | 860-0008 | Japan |
| GSK Investigational Site | Kumamoto | 860-8556 | Japan |
| GSK Investigational Site | Mie | 514-8507 | Japan |
| GSK Investigational Site | Nagano | 399-0021 | Japan |
| GSK Investigational Site | Nagasaki | 859-3615 | Japan |
| GSK Investigational Site | Niigata | 951-8520 | Japan |
| GSK Investigational Site | Okayama | 701-1192 | Japan |
| GSK Investigational Site | Shizuoka | 430-8558 | Japan |
| GSK Investigational Site | Shizuoka | 438-8550 | Japan |
| GSK Investigational Site | Tokyo | 113-8655 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111436 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111436 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Unfractionated Heparin (UFH) | The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fondaparinux Sodium (FPX) | The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0. |
| BG001 | Unfractionated Heparin (UFH) | The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0. |
| BG002 | 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 | Full Analysis Set (FAS): 29 and 10 participants, respectively. One participant in each group whose data for the primary efficacy endpoint (contrast-enhanced MDCT) were missing were excluded. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | FAS | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | FAS | Number | participants |
| |||||||||||||||
| Number of Participants with the Indicated Body Weight | Participants were weighed at Screening (within 10 days before randomization). FAS | Number | participants |
|
| 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 Recurrent or New Symptomatic Venous Thromboembolism (VTE) | VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). | Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute symptomatic deep vein thrombosis (DVT) | Posted | Number | percentage of participants | From Day 1 to Day 90 (±7 days) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type) | VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE. | FAS | Posted | Number | percentage of participants | From Day 1 to Day 90 (±7 days) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline | Classifications of "Improved," "No change," or "Worse" were adjudicated blindly by the CIACE. | FAS | Posted | Number | percentage of participants | Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day) |
| |||||||||||||||||||||||||||||||
| Secondary | Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10 | Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). | FAS | Posted | Mean | Standard Deviation | points on a scale | Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Bleeding Event | Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). | Safety Population: all participants who received at least one dose of medication (FPX or UFH). | Posted | Number | percentage of participants | Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min). |
|
SAEs and AEs were evaluated during the initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr].
SAEs, serious adverse events; AEs, adverse events. CLcr was determined at the last dose of FPX/UFH; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min). CLcr was calculated according to the Cockcroft and Gault formula: CLcr = (140 - age) × weight (kilograms)/(72 × serum creatinine [mg/dL]) × 0.85 (in case of women).
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 | Fondaparinux Sodium (FPX) | The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0. | 1 | 29 | 18 | 29 | ||
| EG001 | Unfractionated Heparin (UFH) | The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0. | 1 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (12.1) | 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 |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006025 | Glycosaminoglycans |
Not provided
Not provided
| Male |
|
| 50-100 kg |
|
| >100 kg |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|