Last updated: 11/07/2018 15:41:27
A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of GI198745 in the treatment and modification of progression of benign prostatic hyperplasia
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, parallel-group study of the efficacy and safety of GI198745 in the treatment and modification of progression of benign prostatic hyperplasia
Trial description: A randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of GI198745 in the treatment and modification of progression of benign prostatic hyperplasia
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:
Abstract: Effect of dutasteride on tue incidence of prostate cancer (pca) in men with benign prostatic hyperplasia. GeraldAndriole, Claus Roehrborn Claude Schulman Kevin Slawin Matt Somerville Roger Rittmaster. 99th Annual Meeting of the American Urological Association 5/8/2004
Abstract: Efficacy and safety of long-term treatment with the dual 5-alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Debruyne, F., Barkin, J., Van Erps, P., Reis, M., Tammela, T. L., Roehrborn, C., and ARIA3001, 3002 and ARIB3003 Study Investigators 27th Congress of the Societe Internationale dUrologie 10/3/2004 Honolulu, HI; USA
Andriole G, Roehrborn CG, Nickel CJ, et al. Effect of the dual 5alpha-reductase inhibitor dutasteride on serum total PSA, free PSA and the ratio of F/T PSA. AUA 2002
Andriole G, Roehrborn CG, Schulman C, et al. Effect of dutasteride on the incidence of prostate cancer (PCa) in men with benign prostatic hyperplasia. AUA 2004
Boyle P, Andriole G, Nickel CJ, et al. Effect of the dual 5alpha-reductase inhibitor dutasteride on total and transitional zone prostate volume. SIU 2002
Boyle P, Robertson C, Wilson T, et al. Risk factors for acute urinary retention in men with benign prostatic hyperplasia. EAU 2003
Boyle P, Roehrborn C, Andriole G, et al. The impact of dutasteride, a novel 5alpha-reductase inhibitor, on the hallmarks of BPH progression and outcomes. EAU 2002
Boyle P, Roehrborn C, 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
Boyle P. Early use of dutasteride arrests prostate growth, improves clinical parameters and prevents complications in men with benign prostatic hyperplasia. AUA 2003
Boyle P. Predictive model for acute urinary retention in man with benign prostatic hyperplasia. AUA 2003
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
Debruyne F, Barkin J, Van Erps P, et al. Efficacy and safety of long-term treatment with the dual 5a-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol; 46(4): 488495
Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Roehrborn, C. G., Marks, L. S., Fenter, T., Freedman, S., Tuttle, J., Gittleman, M., Morrill, B., and Wolford, E. T. Urology 2004; 63 (4):709-15.
Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Debruyne, F., Barkin, J., van Erps, P., Reis, M., Tammela, T. L., and Roehrborn, C. Eur Urol 2004; 46 (4):488-94; discussion 495.
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
Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies. Roehrborn, C. G., Lukkarinen, O., Mark, S., Siami, P., Ramsdell, J., and Zinner, N. BJU Int 2005; 96 (4):572-7.
O'Leary MP, Roehrborn CG, Andriole G, et al. Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5alpha-reductase inhibitor. BJU International 2003; 92: 262-6.
Roehrborn C. Dutasteride provides sustained and continued improvement in BPH-related symptoms over 4 years. AUA 2003
Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5 alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002; 60: 434-441.
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
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)
October 1997 to March 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
2003-20-03
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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