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NCT01178853 · ClinicalTrials.gov registry record · Phase 4
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
A Phase 4 study, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT01178853: Completed Phase 4 study, sponsored by Kowa Research Institute.
NCT01178853 is a Phase 4 study that has completed, run by Kowa Research Institute. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178853, a Phase 4 study, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Primary Outcome
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)
Interventions
- DRUG Warfarin
- DRUG Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
- DRUG Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
What the finished NCT01178853 record still lists
NCT01178853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Warfarin is the first listed.
NCT01178853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01178853 about?
NCT01178853 is a clinical study titled "Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers". This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
What is the current status of trial NCT01178853?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2010-07. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01178853?
The interventions under investigation include: Warfarin (DRUG), Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) (DRUG), Warfarin 5 mg + Pitavastatin 4mg once daily (QD) (DRUG).
Who is sponsoring clinical trial NCT01178853?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01178853's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 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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