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This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin/Rosuvastatin | Experimental |
| |
| Rosuvastatin/Pitavastatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Warfarin 5 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Mean Change From Baseline of International Normalized Ratio (INR) | INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI) | 22 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
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14 July 2010 - 09 November 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin/Rosuvastatin | |
| FG001 | Rosuvastatin/Pitavastatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Warfarin Titration) |
|
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| Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) | Drug | Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) |
|
| Warfarin 5 mg + Pitavastatin 4mg once daily (QD) | Drug | Warfarin 5 mg + Pitavastatin 4mg |
|
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (Warfarin + Study Drug) |
|
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| Period 3 (Warfarin Titration) |
|
|
| Period 4 (Warfarin + Study Drug) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin/Rosuvastatin | |
| BG001 | Rosuvastatin/Pitavastatin | |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Percent Mean Change From Baseline of International Normalized Ratio (INR) | INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI) | Posted | Mean | Standard Deviation | percent change | 22 Days |
|
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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 | Warfarin + Pitavastatin | 0 | 42 | 6 | 42 | |||
| EG001 | Warfarin + Rosuvastatin | 0 | 43 | 3 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA |
| ||
| Headache | Nervous system disorders | MedDRA |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Morgan, MD, FACS | Kowa Research Institute, Inc. | 919-433-1600 | RMorgan@KowaUS.com |
| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000068718 | Rosuvastatin Calcium |
| C108475 | pitavastatin |
| 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 |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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| >=65 years |
|
| Male |
|