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NCT01323998 Clinical Trial

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Prostatic Hyperplasia Clinical Trial

Official title:
Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01323998
Other study ID # 114462
Secondary ID
Status Completed
Phase N/A
First received March 24, 2011
Last updated February 16, 2012
Start date April 2010
Est. completion date June 2010

Study information
Verified date August 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: No Health Authority
Study type Observational

Clinical Trial Summary

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

Recruitment information / eligibility
Status Completed
Enrollment 35032
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:

- Male

- aged 50 years or older

- a diagnostic claim for BPH

- at least one prescription claim for a 5ARI or AB in the enrollment period

- continuous eligibility for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

- diagnosis of prostate or bladder cancer during the study period

- any prostate-related surgical procedure within 1 month of the index prescription date

- prescription claim for finasteride 1 mg for male pattern baldness during the study period

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• 5ARI
Dutasteride or Finasteride
• AB
Doxazosin, Prazosin, 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 by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim. 4 years No
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