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Tracking Information | |||||
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First Received Date † | August 24, 2004 | ||||
Last Updated Date | May 7, 2009 | ||||
Start Date † | November 2003 | ||||
Current Primary Outcome Measures † |
Efficacy of combination treatment in the symptomatic improvement of BPH after 2 years of treatment. Efficacy of combination treatment in the clinical outcomes of AUR or BPH-related surgery after 4 years. [ Time Frame: 2 years ] | ||||
Original Primary Outcome Measures † |
Efficacy of combination treatment in the symptomatic improvement of BPH after 2 years of treatment. Efficacy of combination treatment in the clinical outcomes of AUR or BPH-related surgery after 4 years. | ||||
Change History | Complete list of historical versions of study NCT00090103 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Efficacy of combination treatment in the reduction of risk for BPH clinical progression after 4 years. Effects of combination therapy,on health outcome measures. Safety and tolerability. [ Time Frame: 4 years ] | ||||
Original Secondary Outcome Measures † |
Efficacy of combination treatment in the reduction of risk for BPH clinical progression after 4 years. Effects of combination therapy,on health outcome measures. Safety and tolerability. | ||||
Descriptive Information | |||||
Brief Title † | Benign Prostatic Hyperplasia Trial With AVODART And Tamsulosin Combination Treatment | ||||
Official Title † | See Detailed Description | ||||
Brief Summary | This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually. |
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Detailed Description | A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5mg) and Tamsulosin (0.4mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Benign Prostatic Hyperplasia | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 4500 | ||||
Estimated Completion Date | April 2009 | ||||
Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion criteria:
Insert Inclusion Criteria below: Exclusion Criteria: Required Standard Wording: A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.
Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.
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Gender | Male | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Tunisia, Turkey, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00090103 | ||||
Responsible Party | Study Director, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | May 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |