Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia, alpha blocker
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 661
Healthy volunteers: no

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 1,200 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)

Arms:
arm 1: Silodosin 8 mg per day with food

Interventions: intervention 1: Silodosin
Intervention descriptions: intervention 1: 8 mg daily

Protocol document: