CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Pitavastatin 4mgdrug
Likely dose
Pitavastatin 4mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01043094
NCT01043094Phase 4Completed
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A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers

Kowa Research Institute, Inc.·interventional·Posted Jan 6, 2010·Updated Aug 13, 2012

In Brief

A Phase 4 clinical trial evaluating Pitavastatin 4mg for Severe Renal Impairment. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Renal Impairment
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2010
Enrollment StartDec 1, 2009
Primary CompletionApr 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.5 years ago

Interventions

Pitavastatin 4mgdrug

Pitavastatin 4mg single dose