Last updated: 11/07/2018 15:33:28
A multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy of GI198745 0.5mg Once Daily versus finasteride 5mg Once Daily for 12 months in the treatment of subjects with benign prostatic hyperplasia (BPH). (EPICS)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy of GI198745 0.5mg Once Daily versus finasteride 5mg Once Daily for 12 months in the treatment of subjects with benign prostatic hyperplasia (BPH). (EPICS)
Trial description: A multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy of GI198745 0.5mg Once Daily versus finasteride 5mg Once Daily for 12 months in the treatment of subjects with benign prostatic hyperplasia (BPH). (EPICS)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nickel C, Gilling P, Tammela TLJ, Morrill B, Wilson T, Rittmaster R. Comparison of dutasteride and finasteride for the treatment of benign prostatic hyperplasia in the Enlarged Prostate International Comparator Study (EPICS). BJU Int. 2011;108(3):388-94.
Abstract: Efficacy of dutasteride and finasteride for the treatment of benign prostate hyperplasia: results of the 1-year enlarged prostate international comparator study (epics). GILLING, P. J., JACOBI, G., TAMMELA, T. L., and VAN ERPS, P. Annual Scientific Meeting of the Urological Society of Australasia 2/13/2005 Melbourne; Australia
Andriole GL and Kirby R. Safety and Tolerability of the Dual 5 alpha Reductase Inhibitor Dutasteride in the Treatment of Benign Prostatic Hyperplasia. European Urology 44 (July 2003) 82-88
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
November 1998 to February 2003
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-10-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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