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NCT01043094 · ClinicalTrials.gov registry record · Phase 4
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
A Phase 4 study of Severe Renal Impairment, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01043094 is a Phase 4 study of Severe Renal Impairment that has completed, run by Kowa Research Institute. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01043094, a Phase 4 study of Severe Renal Impairment, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pitavastatin 4mg
Study Locations (1)
Minnesota
- - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01043094
The ClinicalTrials.gov registry entry for NCT01043094 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kowa Research Institute, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Severe Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which Pitavastatin 4mg is the first listed.
NCT01043094 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01043094 about?
NCT01043094 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers". 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 demographi...
What is the current status of trial NCT01043094?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2009-12. Estimated completion is 2010-12.
What conditions does trial NCT01043094 study?
This clinical trial studies the following conditions: Severe Renal Impairment.
What interventions are being tested in trial NCT01043094?
The interventions under investigation include: Pitavastatin 4mg (DRUG).
Who is sponsoring clinical trial NCT01043094?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01043094 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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