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This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):
The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4mg renal impaired | Experimental | Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis |
|
| Pitavastatin 4mg healthy subjects | Active Comparator | Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin 4mg | Drug | Pitavastatin 4mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) | Area under the curve from start to elimination for Pitavastatin. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 3 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis | Minnesota | United States |
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Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4mg Renal Impaired | Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis |
| FG001 | Pitavastatin 4mg Healthy Subjects | Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4mg Renal Impaired | Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis |
| BG001 | Pitavastatin 4mg Healthy Subjects |
| 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 |
| 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 | Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) | Area under the curve from start to elimination for Pitavastatin. | Posted | Mean | Standard Deviation | nanogram hour per milliliter (ng•h/mL) | 48 hours |
|
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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 | Pitavastatin 4mg Renal Impaired | Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Medra |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Morgan, MD, FACS | Kowa Research Institute, Inc. | 919-433-1600 | RMorgan@KowaUS.com |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Posted | Number | Participants | 3 Days |
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Pitavastatin 4mg Healthy Subjects | Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) | 0 | 8 | 1 | 8 |
| Nausea | Gastrointestinal disorders | MedDRA |
|
| Vomiting | Gastrointestinal disorders | MedDRA |
|
| Fatigue | General disorders | MedDRA |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA |
|
| Polyuria | Renal and urinary disorders | MedDRA |
|
PI not to publish.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |