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NCT01309438 · ClinicalTrials.gov registry record · Phase 1
A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function
A Phase 1 study of Healthy and Renal Insufficiency, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 4
- Study locations
NCT01309438 is a Phase 1 study of Healthy and Renal Insufficiency that has completed, run by Janssen Research & Development. The registered enrollment target is 29 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT01309438, a Phase 1 study of Healthy and Renal Insufficiency, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of rivaroxaban when administered with erythromycin to study participants with mild or moderate renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban administered to study participants with normal renal function.
Conditions Studied
Interventions
- DRUG Rivaroxaban (normal renal function)
- DRUG Rivaroxaban (mild and moderate renal impairment)
- DRUG Erythromycin (normal renal function)
- DRUG Erythromycin (mild and moderate renal function)
Study Locations (4)
Minnesota
- - Minneapolis
- - Saint Paul
Florida
- - Orlando
Tennessee
- - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01309438
The ClinicalTrials.gov registry entry for NCT01309438 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Rivaroxaban (normal renal function) is the first listed.
NCT01309438 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Minnesota, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01309438 about?
NCT01309438 is a clinical study titled "A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function". The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of rivaroxaban when administered with erythromycin to study participants with mild or moderate renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban administered to study participants w...
What is the current status of trial NCT01309438?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-02. Estimated completion is 2012-03.
What conditions does trial NCT01309438 study?
This clinical trial studies the following conditions: Healthy, Renal Insufficiency.
What interventions are being tested in trial NCT01309438?
The interventions under investigation include: Rivaroxaban (normal renal function) (DRUG), Rivaroxaban (mild and moderate renal impairment) (DRUG), Erythromycin (normal renal function) (DRUG), Erythromycin (mild and moderate renal function) (DRUG).
Who is sponsoring clinical trial NCT01309438?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01309438 being conducted?
This trial has 4 study locations across Florida, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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