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

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ClinicalTrials.gov Identifier: NCT02303769
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Tamsulosin HCL 0.4mg Drug: Tamsulosin HCL 0.2mg Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: Tamsulosin HCL 0.2mg
Harnal-D tablet (Tamsulosin HCL 0.2mg)
Drug: Tamsulosin HCL 0.2mg
Tamsulosin HCL 0.2mg once a day
Other Name: Harmal D

Experimental: Tamsulosin HCL 0.4mg
GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)
Drug: Tamsulosin HCL 0.4mg
Tamsulosin HCL 0.4mg once a day
Other Name: GL2702 GLARS-NF1 Tablet




Primary Outcome Measures :
  1. Change from baseline to endpoint in total International Prostate Symptom Score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to endpoint in total International Prostate Symptom Score [ Time Frame: 4 weeks ]
  2. Change from baseline to endpoint in voiding score [ Time Frame: 4 weeks, 8 weeks ]
  3. Change from baseline to endpoint in IPSS QoL [ Time Frame: 4 weeks, 8 weeks ]
  4. Change from baseline to endpoint in Qmax [ Time Frame: 4 weeks, 8 weeks ]
  5. Change from baseline to endpoint in PVR [ Time Frame: 4 weeks, 8 weeks ]
  6. Time to event/proportion of subjects with AUR [ Time Frame: 8 weeks ]
  7. Time to event/proportion of subjects undergoing BPH related prostatic surgery [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303769


Locations
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Korea, Republic of
Eulji general hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
GL Pharm Tech Corporation
Investigators
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Principal Investigator: You T Gun, MD Eulji General Hospital

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Responsible Party: GL Pharm Tech Corporation
ClinicalTrials.gov Identifier: NCT02303769     History of Changes
Other Study ID Numbers: GL2702-301
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GL Pharm Tech Corporation:
Lower Urinary Track Syndrome
Harnal
Tamsulosin HCL 0.4mg
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents