Last updated: 11/07/2018 05:34:56
Adherence Benefits in Tx Enlarged Prostate:Medstat
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Value of Early 5-alpha-reductase Inhibitor (5ARI) Treatment in Patients Receiving Combination 5ARI and Alpha-Blocker (AB) Therapy for Enlarged Prostate (EP)
Trial description: GHO-09-0244: Value Value of Early 5-alpha-reductase Inhibitor (5ARI) Treatment in Patients Receiving Combination 5ARI and Alpha-Blocker (AB) Therapy for Enlarged Prostate (EP) A MarketScan Database Assessment
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To assess the proportion of patients with clinical progression (defined as acute urinary retention [AUR] or prostate-related surgery) in those receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.
Timeframe: Within the defined study period, claims will be assessed for a 7-month time period, beginning after a 5-month outcomes exclusionary peri-period from the date of the first prescription claim for an AB.
Secondary outcomes:
To assess the medical costs in patients receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.
Timeframe: Within the defined study period, medical costs will be assessed for a 7-month time period, beginning after a 5-month outcomes exclusionary peri-period from the date of the first prescription claim for an AB.
To assess the pharmacy costs in patients receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.
Timeframe: Within the defined study period, pharmacy costs will be assessed for the entire 1-year follow-up period from the date of the first prescription claim for an AB.
Interventions:
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Eric J. Kruep, Susan L. Hogue, Michael T. Eaddy, Monica D. Chandra. Clinical and Economic Impact of Early versus Delayed 5a-reductase Inhibitor Therapy in Men on Alpha Blockers for Symptomatic Benign Prostatic Hyperplasia . [P & T]. 2011;36(8):493-507.
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
March 2009 to August 2009
Type
Observational
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
none
- Male patients aged 50 years or older with a medical claim of enlarged prostate and prescription claims for both an AB and 5ARI (5ARI claim must be within 6 months of initiating an AB). Patients were required to be continuously eligible for 6 months prior to and at least 12 months after index prescription date.
- Patients with prostate or bladder cancer; any prostate-related surgical procedure or any surgical procedure prior to the index prescription date and in the 5 month peri-period; prescription claim for finasteride indicative of male pattern baldness
Inclusion and exclusion criteria
Inclusion criteria:
- Male patients aged 50 years or older with a medical claim of enlarged prostate and prescription claims for both an AB and 5ARI (5ARI claim must be within 6 months of initiating an AB). Patients were required to be continuously eligible for 6 months prior to and at least 12 months after index prescription date.
Exclusion criteria:
- Patients with prostate or bladder cancer; any prostate-related surgical procedure or any surgical procedure prior to the index prescription date and in the 5 month peri-period; prescription claim for finasteride indicative of male pattern baldness
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2009-20-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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