Last updated: 11/07/2018 04:53:46
5ARI vs combo adherence in EP
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Adherence of patients taking 5ARI vs 5ARI + alpha blocker combination therapy in Enlarged Prostate
Trial description: GHO-09-0242: Adherence of patients taking 5ARI vs 5ARI + alpha blocker combination therapy in Enlarged Prostate
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To describe the proportion of patients adherent to therapy with 5ARI monotherapy vs 5ARI plus AB.
Timeframe: Within the defined study period, claims will be assessed for a 1 year time period after the date of the first prescription claim for an AB or 5ARI related to a diagnosis of enlarged prostate.
Secondary outcomes:
To describe the length of time (days) that patients remained adherent to therapy with 5ARI monotherapy vs 5ARI plus AB.
Timeframe: Within the defined study period, claims will be assessed for a 1 year time period after the date of the first prescription claim for an AB or 5ARI related to a diagnosis of enlarged prostate.
Interventions:
Drug: 5ARI plus AB
Drug: 5ARI monotherapy
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Kruep E, Phillips E, Hogue SL, Eaddy MT . Early Symptom Improvement and Discontinuation of 5-Alpha Reductase Inhibitor (5ARI) Therapy in Patients with Benign Prostatic Hyperplasia (BPH). Ann Pharmacother. 2014;48:343-348.
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
February 2009 to July 2009
Type
Observational
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
none
- Male patients aged 50 years or greater with at least one medical claim of enlarged prostate during the study period and at least one prescription claim of a 5ARI with or without an AB. Patients were required to be continuously eligible for 6 months prior to and at least 6 months after their index prescription date.
- Patients with prostate or bladder cancer; any prostate-related surgical procedure within 6 months prior to the index prescription date; prescription claim for finasteride indicative of male pattern baldness; less than 15 days of initial treatment; 5ARI initiated greater than 30 days after AB initiation; AB initiated any time after 5ARI therapy initiation for patients in the 5ARI monotherapy cohort
Inclusion and exclusion criteria
Inclusion criteria:
- Male patients aged 50 years or greater with at least one medical claim of enlarged prostate during the study period and at least one prescription claim of a 5ARI with or without an AB. Patients were required to be continuously eligible for 6 months prior to and at least 6 months after their index prescription date. -
Exclusion criteria:
- Patients with prostate or bladder cancer; any prostate-related surgical procedure within 6 months prior to the index prescription date; prescription claim for finasteride indicative of male pattern baldness; less than 15 days of initial treatment; 5ARI initiated greater than 30 days after AB initiation; AB initiated any time after 5ARI therapy initiation for patients in the 5ARI monotherapy cohort -
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
2009-16-07
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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