Clinical Trials Directory

Trials / Completed

CompletedNCT01381510

Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Status
Completed
Phase
Study type
Observational
Enrollment
54,459 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

Summary

Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs. The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters. The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009. This study is a retrospective cohort analysis of medical claims data.

Conditions

Interventions

TypeNameDescription
DRUG5-alpha Reductase Inhibitor (5ARI)A 5ARI: Either dutasteride or finisteride

Timeline

Start date
2010-06-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2011-06-27
Last updated
2012-08-27

Source: ClinicalTrials.gov record NCT01381510. Inclusion in this directory is not an endorsement.