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ARI103094-Follow-Up Study for REDUCE Study Subjects


N/A
50 Years
N/A
Not Enrolling
Male
Neoplasms, Prostate

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Trial Information

ARI103094-Follow-Up Study for REDUCE Study Subjects


Inclusion Criteria:

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 Criteria: 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.

Exclusion Criteria: PART B

- The exclusion criterion only applies to Part A, the 2 year Observational Follow-Up
Study. There are no exclusion criteria for Part B, Prostate Biopsy Tissue Study.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

103094

NCT ID:

NCT00883909

Start Date:

April 2009

Completion Date:

December 2010

Related Keywords:

  • Neoplasms, Prostate
  • Prostate Cancer
  • Benign Prostatic Hyperplasia
  • Neoplasms
  • Prostatic Neoplasms

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