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NCT01549951 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01549951: Completed Phase 2 study, sponsored by Millennium Pharmaceuticals.
NCT01549951 is a Phase 2 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01549951, a Phase 2 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer
Primary Outcome
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximu
Interventions
- DRUG Orteronel+Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT01549951 record still lists
NCT01549951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Orteronel+Prednisone is the first listed.
NCT01549951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01549951 about?
NCT01549951 is a clinical study titled "Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer". The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer
What is the current status of trial NCT01549951?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-05. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01549951?
The interventions under investigation include: Orteronel+Prednisone (DRUG).
Who is sponsoring clinical trial NCT01549951?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01549951's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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