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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00090103 |
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.
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Drug: AVODART Drug: Tamsulosin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Enrollment: | 4500 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ARI40005 |
Study First Received: | August 24, 2004 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00090103 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
BPH Combination Therapy Dutasteride |
Dutasteride Neurotransmitter Agents Hyperplasia Adrenergic Agents Prostatic Diseases |
Prostatic Hyperplasia Tamsulosin Adrenergic Antagonists Adrenergic alpha-Antagonists Genital Diseases, Male |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Prostatic Diseases Adrenergic Agents Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Adrenergic alpha-Antagonists Genital Diseases, Male |
Pharmacologic Actions Dutasteride Hyperplasia Pathologic Processes Prostatic Hyperplasia Therapeutic Uses Tamsulosin Adrenergic Antagonists |