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NCT01594255 · ClinicalTrials.gov registry record · Phase 1

CAEB071 Thorough QTc Study in Healthy Volunteers

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
100
Enrollment target

NCT01594255 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 100 participants.

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The verdict

NCT01594255, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target

Study Summary

This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

Interventions

  • DRUG sotrastaurin
  • DRUG placebo to sotrastaurin
  • DRUG Avelox

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2009-07
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01594255

The ClinicalTrials.gov registry entry for NCT01594255 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which sotrastaurin is the first listed.

NCT01594255 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01594255 about?

NCT01594255 is a clinical study titled "CAEB071 Thorough QTc Study in Healthy Volunteers". This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

What is the current status of trial NCT01594255?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2009-07.

What interventions are being tested in trial NCT01594255?

The interventions under investigation include: sotrastaurin (DRUG), placebo to sotrastaurin (DRUG), Avelox (DRUG).

Who is sponsoring clinical trial NCT01594255?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.