Prostatic Hyperplasia Clinical Trial
Official title:
Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
| Verified date | May 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
| Status | Completed |
| Enrollment | 332 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Males - aged 50 years or older - medical claim of EP - prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date) - continuously eligible for 3 months prior to and at least 5 months after their index prescription date. Exclusion Criteria: - Patients with prostate or bladder cancer - any prostate-related surgical procedure within 5 months of index date - prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Clinical Progression | Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery. | 3 months prior to and 12 months following index date | |
| Secondary | Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample. | 3 months prior to and 12 months following index date |
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