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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01594255 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-07 |
| Phase | Phase 1 |
What the finished NCT01594255 record still lists
NCT01594255 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 3 interventions - of which sotrastaurin is the first listed.
NCT01594255 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01594255's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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