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The primary objective 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 PE in an open-label design.
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| 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 |
|---|---|---|
| The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) | VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [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 |
|---|---|---|
| The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) | VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). | From Day 1 to Day 90 (±7 days) |
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Inclusion Criteria:
Exclusion Criteria:
Shock or hemodynamic instability*.
*: Defined as shock or decreased blood pressure (systolic blood pressure <90 mmHg or >=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
Right cardiac function failure detected by echocardiography at screening.
Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current PE.
Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present.
Prior to entry into the study, therapeutic dosage of anticoagulants for more than 24 hours to treat the current episode.
Active, clinically significant bleeding
Thrombocytopenia (platelet count <10×10⁴/µL at screening)
Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension*, or severe diabetes) or bleeding tendency.
*: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
Severe hepatic disorder
Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
Previous history of cerebral hemorrhage
Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
Previous history of Heparin-induced thrombocytopenia
Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant).
Severe renal disorder (serum creatinine >2.0 mg/dL [180 µmol/L] at screening) in a well hydrated subject
Documented hypersensitivity to contrast media
Use of any contraindicated drug that cannot be combined with the injection of contrast medium [e.g., antihyperglycemic metformin hydrochloride (Glycoran®, Melbin®)]
Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
Previous participation in a study of GSK576428
Drug or alcohol abuse
Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
Recent surgery within 3 days prior to entry into the study
Life expectancy <3 months
Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
Others whom the investigator or subinvestigator considers not eligible for the study
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| 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 |
|---|---|---|---|
| 106206 | 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.
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| 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 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 |
|
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|
| 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. |
|
| The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse |
"Improved," "No change," or "Worse" was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE. |
| Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1) |
| Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10 | 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 Central Independent Adjudication Committee of Efficacy (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, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1) |
| The Percentage of Participants With a Bleeding Event | Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). | FPX or UFH treatment period (Days 5-10, on average) |
| Chiba |
| 260-8677 |
| Japan |
| GSK Investigational Site | Fukuoka | 802-8555 | Japan |
| GSK Investigational Site | Gunma | 370-0829 | Japan |
| GSK Investigational Site | Gunma | 371-8511 | 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 | Kumamoto | 860-0008 | Japan |
| GSK Investigational Site | Kumamoto | 860-8556 | Japan |
| GSK Investigational Site | Mie | 514-8507 | Japan |
| GSK Investigational Site | Nagano | 390-8621 | 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 | Osaka | 530-8480 | Japan |
| GSK Investigational Site | Osaka | 540-0006 | Japan |
| GSK Investigational Site | Osaka | 565-8565 | Japan |
| GSK Investigational Site | Saitama | 351-0102 | Japan |
| GSK Investigational Site | Tokyo | 104-8560 | Japan |
| GSK Investigational Site | Tokyo | 113-8603 | Japan |
| GSK Investigational Site | Tokyo | 113-8655 | Japan |
| GSK Investigational Site | Tokyo | 160-8582 | Japan |
| GSK Investigational Site | Tokyo | 180-8610 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106206 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106206 | Individual Participant Data Set | 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 to 2.5 times control and 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. |
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| 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 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 to 2.5 times control and 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 | Analysis population was 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 pulmonary thromboembolism (PE). | Mean | Standard Deviation | years |
| ||||||||||||||
| Gender | Analysis population was 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 pulmonary thromboembolism (PE). | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Analysis population was 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 pulmonary thromboembolism (PE). | Number | participants |
| |||||||||||||||
| Body weight | Participants were weighed at screening (within 10 days before randomisation). Analysis population was 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 pulmonary thromboembolism (PE). | Number | kilograms (kg) |
|
| 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 | The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) | VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [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 pulmonary thromboembolism (PE) | Posted | Number | percentage of participants | From Day 1 to Day 90 (±7 days) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) | VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [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 pulmonary thromboembolism (PE) | Posted | Number | percentage of participants | From Day 1 to Day 90 (±7 days) |
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse | "Improved," "No change," or "Worse" was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the 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 pulmonary thromboembolism (PE) | Posted | Number | percentage of participants | Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1) |
| |||||||||||||||||||||||||||||||
| Secondary | Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10 | 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 Central Independent Adjudication Committee of Efficacy (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). | 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 pulmonary thromboembolism (PE) | Posted | Mean | Standard Deviation | points on a scale | Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1) |
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With a Bleeding Event | Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major 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 | FPX or UFH treatment period (Days 5-10, on average) |
|
FPX or UFH treatment period (Days 5-10 days, on average)
SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication [FPX or UFH]). One participant was randomized to UFH, but was incorrectly administered FPX.
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| 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 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 | 31 | 17 | 31 | ||
| EG001 | Unfractionated Heparin (UFH) | The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and 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. | 0 | 10 | 8 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Occult blood | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Genital erosion | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (11.1) | 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 |
|---|---|
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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Not provided
| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006025 | Glycosaminoglycans |
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| Male |
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| 50-100 kg |
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