Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323998
First received: March 24, 2011
Last updated: February 16, 2012
Last verified: August 2011
  Purpose

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)


Condition Intervention
Prostatic Hyperplasia
Drug: 5ARI
Drug: AB

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 35032
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
5ARI monotherapy
Patients with BPH receiving 5ARI monotherapy
Drug: 5ARI
Dutasteride or Finasteride
AB monotherapy
Patients with BPH receiving AB monotherapy
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Early combination (5ARI + AB) therapy
Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy
Drug: 5ARI
Dutasteride or Finasteride
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed combination (5ARI + AB) therapy
Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy
Drug: 5ARI
Dutasteride or Finasteride
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male patients aged 50 years or older with a diagnostic claim for BPH and at least one prescription claim for a 5ARI or AB in the enrollment period

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323998

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01323998     History of Changes
Other Study ID Numbers: 114462
Study First Received: March 24, 2011
Results First Received: February 16, 2012
Last Updated: February 16, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
enlarged prostate
Benign prostatic hyperplasia
alpha-blocker
5-alpha-reductase inhibitor

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014