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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00421421 |
The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of dutasteride (0.5mg once daily) following a single episode of AUR followed by successful Trial Without Catheter compared with placebo.
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Drug: Dutasteride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase IV Study to Evaluate the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Daily for 24 Weeks to Reduce The Risk of Acute Urinary Retention Relapse Following Successful Trial Without Catheter. |
Estimated Enrollment: | 276 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
GSK Clinical Trials Call Center | |
Crewe, United Kingdom, CW1 4QJ | |
GSK Clinical Trials Call Center | |
Wakefield, United Kingdom, WF1 4DG | |
GSK Clinical Trials Call Center | |
Torquay, United Kingdom, TQ2 7AA | |
GSK Clinical Trials Call Center | |
Bath, United Kingdom, BA1 1BX | |
GSK Clinical Trials Call Center | |
Plymouth, United Kingdom, PL6 8DH | |
GSK Clinical Trials Call Center | |
Leeds, United Kingdom, LS9 7TF | |
GSK Clinical Trials Call Center | |
Nottingham, United Kingdom, NG5 1PB | |
GSK Clinical Trials Call Center | |
Sutton Coldfield, United Kingdom, B75 7RR | |
GSK Clinical Trials Call Center | |
Hull, United Kingdom, HU16 5JQ | |
GSK Clinical Trials Call Center | |
Sunderland, United Kingdom, SR4 7TP | |
GSK Clinical Trials Call Center | |
Edinburgh, United Kingdom, EH4 2XU | |
GSK Clinical Trials Call Center | |
Oldham, United Kingdom, OL1 2JH | |
GSK Clinical Trials Call Centre | |
Birmingham, United Kingdom, B15 2TH | |
GSK Clinical Trials Call Center | |
Stevenage, United Kingdom, SG1 4AB | |
GSK Clinical Trials Call Center | |
London, United Kingdom, E11 1NR | |
GSK Clinical Trials Call Center | |
Glasgow, United Kingdom, G51 4TF | |
GSK Clinical Trials Call Center | |
Chester, United Kingdom, CH2 1UL | |
GSK Clinical Trials Call Center | |
Colchester, United Kingdom, CO4 5JL | |
GSK Clinical Trials Call Center | |
Bristol, United Kingdom, BS2 8HW | |
GSK Clinical Trials Call Center | |
Barnet, United Kingdom, EN5 3DJ | |
GSK Clinical Trials Call Center | |
Bradford, United Kingdom, BD2 0NA | |
GSK Clinical Trials Call Center | |
Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
GSK Clinical Trials Call Center | |
Ormskirk, United Kingdom, L39 2AZ | |
GSK Clinical Trials Call Centre | |
Derby, United Kingdom, DE22 3NE | |
GSK Clinical Trials Call Center | |
Leicester, United Kingdom, LE5 4PW |
Study Director: | GSK Clinical Trials, BSc MBBS | GlaxoSmithKline |
Study ID Numbers: | ARI106807 |
Study First Received: | January 11, 2007 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00421421 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Acute Urinary Retention Benign Prostatic Hyperplasia Trial Without Catheter |
Dutasteride Hyperplasia Prostatic Diseases Urologic Diseases |
Prostatic Hyperplasia Urination Disorders Genital Diseases, Male Urinary Retention |
Dutasteride Hyperplasia Pathologic Processes Molecular Mechanisms of Pharmacological Action Prostatic Diseases Urologic Diseases |
Prostatic Hyperplasia Urination Disorders Enzyme Inhibitors Genital Diseases, Male Urinary Retention Pharmacologic Actions |