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NCT01447511 · ClinicalTrials.gov registry record · NA
Pharmacogenetics of Warfarin Induction and Inhibition
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT01447511: Completed NA study, sponsored by University of Minnesota.
NCT01447511 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01447511, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
This research study will help determine how a person's genetic makeup affects their response to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. The investigators are investigating the drug interactions with the commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart attacks, and strokes. The investigators chose warfarin for this study because it is a commonly used drug and must be monitored closely to avoid side effects. The investigators are interested in studying whether individuals with certain genetic profiles react differently to warfarin when it is combined with other drugs. This research is being done to see if certain genetic profiles require us to adjust warfarin doses differently than is needed for the general population. Genetic profiles of subjects are determined from their participation in the Pharmacogenetics Registry study (investigator Richard Brundage, University of Minnesota). The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive interaction.
Primary Outcome
Warfarin enantiomer (S-warfarin and R-warfarin) clearance was measured in healthy volunteers genotyped for CYP2C9\*1/\*1, CYP2C9\*1B/\*1B, CYP2C9\*1/\*3, CYP2C9\*2/\*3 and CYP2C9\*3/\*3 to determine the magnitude of the warfarin-fluconazole (inhibition) and warfarin-rifampin (induction) drug interactions.
Interventions
- DRUG Control - Warfarin only
- DRUG Fluconazole - Warfarin
- DRUG Rifampin - Warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01447511 record still lists
NCT01447511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Control - Warfarin only is the first listed.
NCT01447511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01447511 about?
NCT01447511 is a clinical study titled "Pharmacogenetics of Warfarin Induction and Inhibition". This research study will help determine how a person's genetic makeup affects their response to drugs, the ability of the body to break down drugs, and their potential to experience an interaction between drugs. The investigators are investigating the drug interactions with the commonly used anticoa...
What is the current status of trial NCT01447511?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2009-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01447511?
The interventions under investigation include: Control - Warfarin only (DRUG), Fluconazole - Warfarin (DRUG), Rifampin - Warfarin (DRUG).
Who is sponsoring clinical trial NCT01447511?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01447511's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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