Status:
COMPLETED
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
Lead Sponsor:
GL Pharm Tech Corporation
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Over 50 years old, BPH diagnosted, Adult Male Subject
- IPSS ≥ 13 point
- PSA \< 4ng/mL
- 5ml/sec \< Qmax ≤ 15ml/sec
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT02303769
Start Date
March 1 2014
End Date
October 1 2015
Last Update
February 25 2016
Active Locations (1)
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1
Eulji general hospital
Seoul, South Korea