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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01376258 |
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Date of registration:
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16/06/2011 |
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Primary sponsor: |
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Public title:
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Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
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Scientific title:
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Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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28903 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01376258 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male
- Age 65 or older
- A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
- A prescription claim for a 5ARI for at least 60 days during the observation period
- Continuous eligibility for 6 months prior to and at least 91 days after the index
date
Exclusion Criteria:
- A prostate cancer diagnosis
- A procedure cost for any prostate-related surgical procedure prior to the index date
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostatic Hyperplasia
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Intervention(s)
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Drug: 5ARI
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Primary Outcome(s)
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Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery
[Time Frame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)]
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Secondary Outcome(s)
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Adjusted benign prostatic hyperplasia (BPH)-related costs
[Time Frame: 1 year following the first therapy date]
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Medication Possession Ratio (MPR)
[Time Frame: 1 year following the first therapy date]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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