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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: Completed Phase 4 study of Severe Renal Impairment, sponsored by Kowa Research Institute.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the curve from start to elimination for Pitavastatin.
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 |
What the finished NCT01043094 record still lists
NCT01043094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01043094's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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