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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 |
---|---|---|
Benign Prostatic Hyperplasia |
Drug: AVODART Drug: Tamsulosin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
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) |
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:
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.
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | ARI40005 |
Study First Received: | August 24, 2004 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00090103 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
BPH Combination Therapy Dutasteride |
Dutasteride Hyperplasia Prostatic Diseases |
Prostatic Hyperplasia Tamsulosin Genital Diseases, Male |
Neurotransmitter Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Adrenergic Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Adrenergic Antagonists Adrenergic alpha-Antagonists Pharmacologic Actions |