跳至主要内容
临床试验/NCT01323998
NCT01323998已完成不适用

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

GlaxoSmithKline0 个研究点目标入组 35,032 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35,032
主要终点
Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis

研究概览

简要总结

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

5ARI monotherapy

Patients with BPH receiving 5ARI monotherapy

干预措施: 5ARI (Drug)

AB monotherapy

Patients with BPH receiving AB monotherapy

干预措施: AB (Drug)

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

干预措施: 5ARI (Drug)

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

干预措施: AB (Drug)

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

干预措施: 5ARI (Drug)

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

干预措施: AB (Drug)

结局指标

主要结局

Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis

时间窗: 4 years

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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

相似试验