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

A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02303769

Acronym

GL2702

Enrollment

309

Registered

2014-12-01

Start date

2014-03-31

Completion date

2015-10-31

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Lower Urinary Track Syndrome, Harnal, Tamsulosin HCL 0.4mg

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

Interventions

DRUGTamsulosin HCL 0.4mg

Tamsulosin HCL 0.4mg once a day

DRUGTamsulosin HCL 0.2mg

Tamsulosin HCL 0.2mg once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline to endpoint in total International Prostate Symptom Score	8 weeks

Secondary

Measure	Time frame
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 total International Prostate Symptom Score	4 weeks
Time to event/proportion of subjects with AUR	8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery	8 weeks
Change from baseline to endpoint in PVR	4 weeks, 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026