Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GL Pharm Tech Corporation
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• Over 50 years old, BPH diagnosted, Adult Male Subject

• IPSS ≥ 13 point

• PSA < 4ng/mL

• 5ml/sec < Qmax ≤ 15ml/sec

Exclusion Criteria:

• Prostatic cancer

• 250ml < PVR

• ALT or AST > 2 times (Upper Normal Range)

• Total Bilirubin > 1.5 times (Upper Normal Range)

• Treated with α-adrenalin receptor blocker within 2weeks before screening

• Treated with 5Alpha-Reductase Inhibitor within 6 months before screening

• Treated with phytotherapy within 2weeks before screening

• Treated with Anabolic Steroid within 6 months before screening