Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function

NCT01309438 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 29 participants
Start Date 2011-02
Est. Completion 2012-03
Phase Phase 1

Sponsor

Janssen Research & Development

442 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01309438 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Minnesota, Florida, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01309438?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial