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NCT01386983 Clinical Trial

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Prostatic Hyperplasia Clinical Trial

Official title:
Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01386983
Other study ID # 112599
Secondary ID
Status Completed
Phase N/A
First received February 28, 2011
Last updated May 15, 2017
Start date March 2009
Est. completion date June 2010

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 5ARI
Dutasteride or Finasteride
• 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
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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