Last updated: 11/07/2018 15:33:40
A pilot multi-centre, double-blind, parallel group, randomised study to investigate the effect on symptoms 3 months after discontinuing tamsulosin, following 6 months combination treatment with 0.5mg GI198745 and 0.4mg tamsulosin daily in patients with symptomatic Benign Prostatic Hyperplasia (BPH).
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 pilot multi-centre, double-blind, parallel group, randomised study to investigate the effect on symptoms 3 months after discontinuing tamsulosin, following 6 months combination treatment with 0.5mg GI198745 and 0.4mg tamsulosin daily in patients with symptomatic Benign Prostatic Hyperplasia (BPH).
Trial description: A pilot multi-centre, double-blind, parallel group, randomised study to investigate the effect on symptoms 3 months after discontinuing tamsulosin, following 6 months combination treatment with 0.5mg GI198745 and 0.4mg tamsulosin daily in patients with symptomatic Benign Prostatic Hyperplasia (BPH).
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:
Barkin J, Guimarães M, Jacobi G, et al. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5 alpha-reductase inhibitor dutasteride. Eur Urol 2003; 44: 461–6.
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
February 2000 to March 2001
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
2001-15-03
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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