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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 28, 2011
First Posted Date July 1, 2011
Results First Submitted Date February 28, 2011
Results First Posted Date July 1, 2011
Last Update Posted Date May 17, 2017
Study Start Date March 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2011)
Number of Participants With Clinical Progression [ Time Frame: 3 months prior to and 12 months following index date ]
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01386983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 6, 2011)
Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month [ Time Frame: 3 months prior to and 12 months following index date ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Official Title Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
Brief Summary This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.
Condition Prostatic Hyperplasia
Intervention
  • Drug: 5ARI
    Dutasteride or Finasteride
    Other Names:
    • Avodart® is a registered trademark of GlaxoSmithKline
    • Proscar® is a registered trademark of Merck
  • Drug: 5ARI + AB
    5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
    Other Names:
    • Proscar® is a registered trademark of Merck
    • Hytrin® is a registered trademark of Abbott Laboratories
    • Flomax® is a registered trademark of Astellas Pharma
    • Avodart® is a registered trademark of GlaxoSmithKline
    • Cardura® is a registered trademark of Pfizer Inc
    • Uroxatral® is a registered trademark of Sanofi-Aventis
Study Groups/Cohorts
  • Early 5ARI Initiation
    Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
    Interventions:
    • Drug: 5ARI
    • Drug: 5ARI + AB
  • Late 5ARI Initiation
    Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)
    Interventions:
    • Drug: 5ARI
    • Drug: 5ARI + AB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2011)
332
Original Actual Enrollment Same as current
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males
  • aged 50 years or older
  • medical claim of EP
  • prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
  • continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Exclusion Criteria:

  • Patients with prostate or bladder cancer
  • any prostate-related surgical procedure within 5 months of index date
  • prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01386983
Other Study ID Numbers 112599
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017