Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090103
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2004-08-24
Brief Title:
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride 05mg and Tamsulosin 04mg Administered Once Daily for 4 Years Alone and Combination on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
A randomised double-blind parallel group study to investigate the efficacy and safety of treatment with Dutasteride 05 mg and Tamsulosin 04 mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None