Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359905
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-08-02
Brief Title:
Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
Sponsor:
RECORDATI GROUP
Organization:
RECORDATI GROUP
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Silodosin vs Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH Multicentre Randomised Double-Blind Controlled Trial With an Optional Long-Term Open-Label Extension Phase
Status:
COMPLETED
Status Verified Date:
2009-02
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:
A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin a drug belonging to the same therapeutic class for to determine if it is safe and effective the first phase of the study lasts approximately 18 weeks and then is used for another 9 months to determine its long-term safety
Detailed Description:
This is a multi-centre double-blind placebo and active controlled parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia followed by a 9 month open-label phase The following procedures are used physical exams electrocardiograms clinical laboratory tests vital signs the International Prostate Symptom Score maximum urine flow rate adverse events concomitant medications quality of life and compliance 93 centres in 11 European countries Finland France Germany Italy Netherlands Poland Romania Russia Spain Ukraine UK will be involved
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