NCT02244255

FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia

An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study of FLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (With Titration) Daily in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,993 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

1. To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH) 2. To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the symptoms of benign prostatic hyperplasia

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	FLOMAX® capsules
DRUG	Ascending doses of HYTRIN® capsules

Timeline

• Start date: 1998-08-01
• Primary completion: 2000-06-01
• First posted: 2014-09-19
• Last updated: 2014-09-19