Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

NCT ID: NCT01323998

Last Updated: 2017-07-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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5ARI monotherapy

Patients with BPH receiving 5ARI monotherapy

5ARI

Intervention Type DRUG

Dutasteride or Finasteride

AB monotherapy

Patients with BPH receiving AB monotherapy

AB

Intervention Type DRUG

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

5ARI

Intervention Type DRUG

Dutasteride or Finasteride

AB

Intervention Type DRUG

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

5ARI

Intervention Type DRUG

Dutasteride or Finasteride

AB

Intervention Type DRUG

Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Interventions

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5ARI

Dutasteride or Finasteride

Intervention Type DRUG

AB

Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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114462

Identifier Type: -

Identifier Source: org_study_id

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