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NCT01336140 · ClinicalTrials.gov registry record · Phase 4

Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging

A Phase 4 study, sponsored by Rush University Medical Center.

Completed
Registry status
Phase 4
Development phase
300
Enrollment target

NCT01336140: Completed Phase 4 study, sponsored by Rush University Medical Center.

NCT01336140 is a Phase 4 study that has completed, run by Rush University Medical Center. The registered enrollment target is 300 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01336140, a Phase 4 study, has completed, sponsored by Rush University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
300 participants
Enrollment target

Study Summary

The routine administration of 75 mg of intravenous aminophylline in patients with severe chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.

Primary Outcome

Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion). The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements.

Interventions

  • DRUG Placebo
  • DRUG Aminophylline

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2011-06
Est. Completion 2012-05
Phase Phase 4
Rush University Medical Center

320 total trials

What the finished NCT01336140 record still lists

NCT01336140 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01336140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01336140 about?

NCT01336140 is a clinical study titled "Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging". The routine administration of 75 mg of intravenous aminophylline in patients with severe chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.

What is the current status of trial NCT01336140?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2011-06. Estimated completion is 2012-05.

What interventions are being tested in trial NCT01336140?

The interventions under investigation include: Placebo (DRUG), Aminophylline (DRUG).

Who is sponsoring clinical trial NCT01336140?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01336140's enrollment target sits among peer trials

300 269th of 2000 higher than 1,709 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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Source: ClinicalTrials.gov NCT01336140, the US trial registry maintained by the National Library of Medicine. NCT01336140 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.