Status:
COMPLETED
ARI103094-Follow-Up Study for REDUCE Study Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Prostate
Eligibility:
MALE
50+ years
Brief Summary
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),...
Eligibility Criteria
Inclusion
- PART A
- Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria is eligible for Part A, 2 Year Observational Follow-Up Study:
- Completed 4 years on Investigational Product through the REDUCE 4 Year study visit (Visit 10) OR
- Was diagnosed with prostate cancer during the REDUCE study, discontinued Investigational Product (IP) but participated in REDUCE Prostate Cancer Follow-Up visits through the 4 Year study visit (Visit 10P) OR
- Withdrew from REDUCE study visit participation and IP (for any reasons) but participated in REDUCE Follow-Up phone calls every 6 months through the 4 Year phone call
Exclusion
- PART A Subjects meeting the following criterion must not be enrolled in Part A of the study
- Inability/unwillingness to participate in the Follow-Up Study phone calls.
- Inclusion Criteria: PART B
- Subjects eligible for enrolment in Part B of the study must meet the following criteria:
- Any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the REDUCE Study, regardless of when their REDUCE study participation ended.
Key Trial Info
Start Date :
April 9 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2010
Estimated Enrollment :
2795 Patients enrolled
Trial Details
Trial ID
NCT00883909
Start Date
April 9 2009
End Date
December 29 2010
Last Update
July 11 2017
Active Locations (267)
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1
GSK Investigational Site
Anchorage, Alaska, United States, 99508
2
GSK Investigational Site
Phoenix, Arizona, United States, 85032
3
GSK Investigational Site
Little Rock, Arkansas, United States, 72211
4
GSK Investigational Site
Anaheim, California, United States, 92801