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NCT00363311 · ClinicalTrials.gov registry record · Phase 4
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 302
- Enrollment target
NCT00363311: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00363311 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 302 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.
The verdict
NCT00363311, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 302 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
Primary Outcome
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added
Interventions
- DRUG Matching placebo
- DRUG Dutasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2006-07 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT00363311 record still lists
NCT00363311 is an interventional study that assigns participants to a tested intervention. The registered 302 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 Matching placebo is the first listed.
NCT00363311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00363311 about?
NCT00363311 is a clinical study titled "Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men". The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
What is the current status of trial NCT00363311?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2006-07. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00363311?
The interventions under investigation include: Matching placebo (DRUG), Dutasteride (DRUG).
Who is sponsoring clinical trial NCT00363311?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00363311's enrollment target sits among peer trials
302 266th of 2000 higher than 1,733 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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