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The primary purpose of this study is to optimize drug exposure in the target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone | Experimental | Participants on betrixaban 30 mg and concomitant baseline amiodarone |
|
| Betrixaban 60 mg | Experimental | Participants with lower weights |
|
| Betrixaban 90 mg | Experimental | Participants with higher weights |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug | Patients on Amiodarone |
| |
| Betrixaban 60 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing | Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups | Days 14, 18, and 21 of the PK period |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing | Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups | Days 14, 18, and 21 of the PK period |
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Inclusion Criteria:
Exclusion Criteria:
General
Prohibited Medical Conditions
Prohibited Medications
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Patients weighing < 80 kg received daily betrixaban 60 mg, patients weighing ≥ 80 kg received daily betrixaban 90 mg, and patients on amiodarone at screening, regardless of weight, received daily betrixaban 30 mg. 241 patients were screened for study participation. Of these patients, 189 were enrolled and received at least 1 dose of study drug.
Between 9Sep10 & 22Apr11, 189 patients were enrolled by 68 study centers in 2 countries (USA, Canada). Patients were enrolled to 1 of 3 treatment groups (betrixaban once daily 30, 60 or 90 mg) based on weight or use of amiodarone at screening. The study had an initial pharmacokinetics (PK) phase of 4 weeks and a safety extension phase of 20 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Betrixaban 30 mg (+Amiodarone) | Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone |
| FG001 | Betrixaban 60 mg (<80 kg) | Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Betrixaban 60 mg once a day with food on Day 0 through Day 25 |
|
|
| Betrixaban 90 mg | Drug | Betrixaban 90 mg once a day with food on Day 0 through Day 25 |
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| Betrixaban 30 mg | Drug | Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment. |
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| FG002 | Betrixaban 90 mg (≥80 kg) | Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled patients who took at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Betrixaban 30 mg (+Amiodarone) | Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone |
| BG001 | Betrixaban 60 mg (<80 kg) | Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks |
| BG002 | Betrixaban 90 mg (≥80 kg) | Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing | Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups | Per protocol analysis set, which includes all allocated patients who received at least one dose of study treatment and who were ≥ 90% compliant with study treatment, took study treatment within 24 hours prior to steadystate blood sampling, had at least two post steady-state blood samples collected, and not on amiodarone. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ng/mL | Days 14, 18, and 21 of the PK period |
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| Secondary | Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing | Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups | Full Analysis Set population, which includes all patients who received at least one dose of study treatment within 24 hours prior to steady-state (SS) blood sampling, were ≥ 90% compliant with treatment, and had at least one post SS sample. The endpoint was to summarize the SS C12 hr concentration across treatments and time points as a single arm. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ng/mL | Days 14, 18, and 21 of the PK period |
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Maximum of 24 weeks
Incidence of serious adverse events by system organ class
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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 | Betrixaban 30 mg (+Amiodarone) | Betrixaban 30 mg once daily for at least 4 weeks and up to 24 weeks for patients taking amiodarone | 6 | 42 | 18 | 42 | ||
| EG001 | Betrixaban 60 mg (<80 kg) | Betrixaban 60 mg once daily for at least 4 weeks and up to 24 weeks | 13 | 74 | 34 | 74 | ||
| EG002 | Betrixaban 90 mg (≥80 kg) | Betrixaban 90 mg once daily for at least 4 weeks and up to 24 weeks | 6 | 73 | 35 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Viral infection | Infections and infestations | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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Due to multiple studies, centers and countries this may vary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Portola Pharmaceuticals, Inc. | 650-246-7000 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| C543086 | betrixaban |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=75 years |
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| Male |
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