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

GL Pharm Tech

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tamsulosin HCL 0.2mg; Drug: Tamsulosin HCL 0.4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02303769

GL2702-301

Details and patient eligibility

About

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

Full description

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

Enrollment: 309 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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309 participants in 2 patient groups

Tamsulosin HCL 0.2mg

Active Comparator group

Description:

Harnal-D tablet (Tamsulosin HCL 0.2mg)

Treatment:

Drug: Tamsulosin HCL 0.2mg

Tamsulosin HCL 0.4mg

Experimental group

Description:

GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)

Treatment:

Drug: Tamsulosin HCL 0.4mg