NCT00969072

Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.

Detailed description

Upon completion of 24 weeks of GI198745 0.05 mg, 0.5 mg, 2.5 mg, or placebo therapy in study ARI20005, subjects are enrolled into an extension phase and are continued on the same therapy once daily for up to further 28 weeks, followed by up to 16 weeks of post-dosing assessments.

Conditions

• Benign Prostatic Hyperplasia
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	GI198745 0.05mg	GI198745 (drug) - benign prostatic hyperplasia
DRUG	GI198745 0.5mg	GI198745 (drug) - benign prostatic hyperplasia
DRUG	GI198745 2.5mg	GI198745 (drug) - benign prostatic hyperplasia

Timeline

• Start date: 2003-08-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2009-08-31
• Last updated: 2010-09-13