Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224133
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-14
Brief Title:
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Sponsor:
Watson Pharmaceuticals
Organization:
Watson Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2010-04
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 benign prostatic hyperplasia is used for 9 months to determine its long-term safety
Detailed Description:
This will be a multi-center open-label 40 week investigation in up to 1200 men with signs and symptoms of benign prostatic hyperplasia The following procedures are utilized physical exams electrocardiograms clinical laboratory tests vital signs the International Prostate Symptom Score maximum urine flow rate adverse events concomitant medications and compliance
All subjects had previously participated in a 12-week double-blind placebo controlled trial NCT000224107 or NCT000224120
All subjects had previously participated in a 12-week double-blind placebo controlled trial NCT000224107 or NCT000224120
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