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Trial record 22 of 26 for:    dutasteride AND tamsulosin

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

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ClinicalTrials.gov Identifier: NCT01386983
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : July 1, 2011
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Prostatic Hyperplasia
Interventions Drug: 5ARI
Drug: 5ARI + AB
Enrollment 332
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Cohort Delayed Cohort
Hide Arm/Group Description Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Period Title: Overall Study
Started 264 68
Completed 264 68
Not Completed 0 0
Arm/Group Title Early Cohort Delayed Cohort Total
Hide Arm/Group Description Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) Total of all reporting groups
Overall Number of Baseline Participants 264 68 332
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 264 participants 68 participants 332 participants
>=50 years old 264 68 332
<50 years old 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 264 participants 68 participants 332 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
264
 100.0%
68
 100.0%
332
 100.0%
1.Primary Outcome
Title Number of Participants With Clinical Progression
Hide Description Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Time Frame 3 months prior to and 12 months following index date
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.
Arm/Group Title Early Cohort Delayed Cohort
Hide Arm/Group Description:
Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Overall Number of Participants Analyzed 264 68
Measure Type: Number
Unit of Measure: participants
14 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Cohort, Delayed Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0128
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 3.406
Confidence Interval (2-Sided) 95%
1.297 to 8.941
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month
Hide Description EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.
Time Frame 3 months prior to and 12 months following index date
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population
Arm/Group Title Early Cohort Delayed Cohort
Hide Arm/Group Description:
Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Overall Number of Participants Analyzed 264 68
Mean (95% Confidence Interval)
Unit of Measure: dollars
129.14
(97.42 to 154.19)
254.51
(178.92 to 329.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Cohort, Delayed Cohort
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Generalized linear model
Comments Gamma distribution with log-link function was used.
Time Frame [Not Specified]
Adverse Event Reporting Description This was a retrospective database study, and adverse event/serious adverse event information was not captured in the study.
 
Arm/Group Title Early Cohort Delayed Cohort
Hide Arm/Group Description Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users) Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
All-Cause Mortality
Early Cohort Delayed Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early Cohort Delayed Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Cohort Delayed Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01386983     History of Changes
Other Study ID Numbers: 112599
First Submitted: February 28, 2011
First Posted: July 1, 2011
Results First Submitted: February 28, 2011
Results First Posted: July 1, 2011
Last Update Posted: May 17, 2017