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Sponsors and Collaborators: |
Siami, Paul F., M.D. eraClinical GlaxoSmithKline |
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Information provided by: | Siami, Paul F., M.D. |
ClinicalTrials.gov Identifier: | NCT00701779 |
This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 53 Weeks.
(Including Screening, (up to 7 clinic visits)
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Drug: tamsulosin used with dutasteride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) Once Daily for One Year and Tamsulosin (0.4mg), Administered Once Daily for 3 Months, Followed by Counseling on Flexible Dosing of Tamsulosin on an as Needed Basis, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia (BPH) |
Enrollment: | 60 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
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Drug: tamsulosin used with dutasteride
Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding Screening and/or during the course of this study.
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United States, Indiana | |
Welborn Clinic Research Institute | |
Evansville, Indiana, United States, 47713 | |
Welborn Clinic Research Institute | |
Evansville, Indiana, United States, 47713 |
Responsible Party: | Welborn Clinic Research Institute ( Paul F. Siami, MD ) |
Study ID Numbers: | Siami104907 |
Study First Received: | June 17, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00701779 History of Changes |
Health Authority: | United States: Institutional Review Board |
Benign Prostatic Hyperplasia Dutasteride Tamsulosin |
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 |