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NCT00090103 · ClinicalTrials.gov registry record · Phase 3
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
A Phase 3 study of Prostatic Hyperplasia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,844
- Enrollment target
- 20
- Study locations
NCT00090103 is a Phase 3 study of Prostatic Hyperplasia that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,844 participants, above the 2,092-participant average among 5 other Prostatic Hyperplasia trials with a reported enrollment target (132% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT00090103, a Phase 3 study of Prostatic Hyperplasia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,844 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
Conditions Studied
Interventions
- DRUG dutasteride 0.5mg once daily for 4 years
- DRUG tamsulosin 0.4mg once daily for 4 years
Study Locations (20)
California
- GSK Investigational Site - Beverly Hills
- GSK Investigational Site - Concord
- GSK Investigational Site - Glendora
- GSK Investigational Site - Greenbrae
- GSK Investigational Site - Irvine
- GSK Investigational Site - La Jolla
- GSK Investigational Site - Laguna Woods
- GSK Investigational Site - Los Angelas
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Modesto
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Columbiana
- GSK Investigational Site - Hoover
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix, Arizona
Alaska
- GSK Investigational Site - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,844 participants |
| Start Date | 2003-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00090103
The ClinicalTrials.gov registry entry for NCT00090103 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,844 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,092-participant average among 5 other Prostatic Hyperplasia trials with a reported enrollment target (132% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which dutasteride 0.5mg once daily for 4 years is the first listed.
NCT00090103 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00090103 about?
NCT00090103 is a clinical study titled "Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment". This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study vi...
What is the current status of trial NCT00090103?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,844 participants. The study started on 2003-11. Estimated completion is 2009-04.
What conditions does trial NCT00090103 study?
This clinical trial studies the following conditions: Prostatic Hyperplasia.
What interventions are being tested in trial NCT00090103?
The interventions under investigation include: dutasteride 0.5mg once daily for 4 years (DRUG), tamsulosin 0.4mg once daily for 4 years (DRUG).
Who is sponsoring clinical trial NCT00090103?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00090103 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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