Status:
COMPLETED
Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Brief Summary
In patients with benign prostatic hyperplasia (BPH), combination therapy with an alpha-blocker (AB) and a 5 alpha-reductase inhibitor (5ARI) has been shown to reduce the progression of acute urinary r...
Eligibility Criteria
Inclusion
- Male
- Age 50 or older at the index date (the date of the first filled prescription for an AB or 5ARI during the enrollment period)
- At least one claim with an ICD-9 diagnosis code for BPH (222.2 or 600.xx) in any position and at least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) or at least one fill for a 5ARI (dutasteride or finasteride) (with or without a diagnosis for BPH)
- Continuous enrollment with medical and pharmacy benefits for 6 months prior to the index date (i.e., baseline period) and 12 months after the index date (follow-up period)
Exclusion
- At least one pharmacy claim for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) any time during the pre-index period prior to the index date
- At least one fill for a 5ARI (dutasteride or finasteride) any time during the pre-index period prior to the index date
- A diagnosis code for prostate cancer (ICD-9 = 185, 198.82, 233.4, 236.5, 239.5, V10.46) or bladder cancer (ICD-9 =188, 198.1, 223.3, 233.7, 239.4, V10.51) in any position during the pre-index or follow-up period
- A pharmacy claim for finasteride 1 mg tablets (i.e., treatment of male-pattern baldness) during the pre-index or follow-up period
- Prostate surgery anytime during the pre-index period or 5 months after the index date
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
13551 Patients enrolled
Trial Details
Trial ID
NCT01435954
Start Date
August 1 2010
End Date
March 1 2011
Last Update
May 16 2017
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