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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin HCL 0.2mg; Drug: Tamsulosin HCL 0.4mg

• Registration Number: NCT02303769
• Lead Sponsor: GL Pharm Tech Corporation

Brief 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

Detailed Description

GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Primary Completion: 2015-05
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 309

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin HCL 0.2mg	Tamsulosin HCL 0.2mg	Harnal-D tablet (Tamsulosin HCL 0.2mg)
Tamsulosin HCL 0.4mg	Tamsulosin HCL 0.4mg	GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in total International Prostate Symptom Score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in total International Prostate Symptom Score	4 weeks
Change from baseline to endpoint in voiding score	4 weeks, 8 weeks
Change from baseline to endpoint in IPSS QoL	4 weeks, 8 weeks
Change from baseline to endpoint in Qmax	4 weeks, 8 weeks
Change from baseline to endpoint in PVR	4 weeks, 8 weeks
Time to event/proportion of subjects with AUR	8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery	8 weeks

Trial Locations

Locations (1)

Eulji general hospital; 🇰🇷 Seoul, Korea, Republic of