Last updated: 11/07/2018 15:40:55
A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel Group Study of the Efficacy and Safety of Dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Open-Label Treatment Phase).
GSK study ID
ARIA3001
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 Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel Group Study of the Efficacy and Safety of Dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Open-Label Treatment Phase).
Trial description: A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel Group Study of the Efficacy and Safety of Dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Open-Label Treatment Phase).
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:
Debruyne F, Barkin J, Roehrborn CG. Long-term dutasteride therapy results in continued improvements in symptoms and peak urinary flow in men with symptomatic benign prostatic hyperplasia. EAU 2004
Emberton M. Earlier initiation of treatment with the dual 5alpha reductase inhibitor dutasteride reduces the risk of acute urinary retention and surgical intervention in men with benign prostatic hyperplasia. EAU 2004
Fenter T, Tully A, Debruyne F. Long-term therapy with the dual 5alpha reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia. AUA 2004
Freedman S, Brosman S, Emberton M, et al. Earlier initiation of treatment with the dual 5alpha reductase inhibitor dutasteride reduces the risk of acute urinary retention and surgical intervention in men with benign prostatic hyperplasia. AUA 2004
Gittelman M, Barkin J, Zinner N. Sustained prostate volume reduction with dutasteride over 4 years is independent of baseline prostate volume. AUA 2004
Roehrborn C. Dutasteride provides sustained and continued improvement in BPH-related symptoms over 4 years. AUA 2003
Roehrborn CG, Dineen M, Bock D, et al. Change in symptom severity status in 4-year dutasteride studies in men with symptomatic BPH. AUA 2004
Roehrborn CG, Marks L, Fenter T, et al. Long-term dutasteride therapy results in continued improvements in symptoms and peak urinary flow in men with symptomatic benign prostatic hyperplasia. AUA 2004
Roehrborn CG, Marks LS, Fenter T, et al. Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Urology 2004; 63: 709-15.
Tammela T, Barkin J, Roehrborn CG. Long-term dutasteride therapy results in sustained reductions in total prostate volume in men with symptomatic benign prostatic hyperplasia. EAU 2004
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
September 1997 to November 2002
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
No study documents available.
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-21-11
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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