Viewing Study NCT00224107



Ignite Creation Date: 2024-05-05 @ 12:02 PM
Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00224107
Status: COMPLETED
Last Update Posted: 2011-07-12
First Post: 2005-09-14

Brief Title: A New Drug for Benign Prostatic Hyperplasia BPH Compared With Placebo
Sponsor: Watson Pharmaceuticals
Organization: Watson Pharmaceuticals

Study Overview

Official Title: A Multi-Center Randomized Double-Blind Placebo Controlled Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Status: COMPLETED
Status Verified Date: 2011-07
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 compared to placebo for to determine if it is safe and effective The study lasts approximately 20 weeks
Detailed Description: This will be a multi-center double-blind placebo controlled parallel 12 week treatment trial in 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 pharmacokinetics adverse events concomitant medications quality of life and compliance

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