An observational study in Neoplasms, Prostate, sponsored by GlaxoSmithKline. Completed at 267 sites in 12 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by GlaxoSmithKline · Observational
ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2,795 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with or without prostate cancer that participated in the REDUCE trial
Inclusion Criteria: PART A
Exclusion Criteria: PART A Subjects meeting the following criterion must not be enrolled in Part A of the study
Inclusion Criteria: PART B
Subjects eligible for enrolment in Part B of the study must meet the following criteria:
Exclusion Criteria: PART B
A follow-up study in adult male subjects who have received investigational
Drug: dutasteride
A follow-up study in adult male subjects who have received investigational product
To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
Time frame: 2 years
To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
Time frame: 2 years
Showing the first 100 of 267 sites across 12 countries.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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