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Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tamsulosin 0.4mg
Tamsulosin 0.2mg
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Severe LUTS : IPSS ≥ 20

Exclusion Criteria:

  • Post voided residual urine ≥ 150mL
  • Patients performing catheterization
  • Urinary tract infection patients
  • Patients taking 5 alpha reductase inhibitor
  • Known hypersensitivity to tamsulosin
  • History of postural hypotension or syncope
  • Hypertension patients treated with other alpha1-blockers
  • Patients newly taking anticholinergic medication within 1 month
  • Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
  • Renal insufficiency (s-Cr ≥ 2mg/dL)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tamsulosin 0.4mg

    tamsulosin 0.2mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)

    Secondary Outcome Measures

    Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
    Changes of parameters in voiding diary after 4 and 12 weeks treatment.

    Full Information

    First Posted
    July 26, 2011
    Last Updated
    July 30, 2011
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01404637
    Brief Title
    Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
    Official Title
    The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    July 2013 (Anticipated)
    Study Completion Date
    October 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tamsulosin 0.4mg
    Arm Type
    Experimental
    Arm Title
    tamsulosin 0.2mg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin 0.4mg
    Intervention Description
    Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin 0.2mg
    Intervention Description
    tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
    Primary Outcome Measure Information:
    Title
    Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
    Time Frame
    12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
    Time Frame
    4 weeks and 12 weeks of treatment
    Title
    Changes of parameters in voiding diary after 4 and 12 weeks treatment.
    Time Frame
    4 weeks and 12 weeks of treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Severe LUTS : IPSS ≥ 20 Exclusion Criteria: Post voided residual urine ≥ 150mL Patients performing catheterization Urinary tract infection patients Patients taking 5 alpha reductase inhibitor Known hypersensitivity to tamsulosin History of postural hypotension or syncope Hypertension patients treated with other alpha1-blockers Patients newly taking anticholinergic medication within 1 month Hepatic insufficiency (AST/ALT ≥ 2 times of normal range) Renal insufficiency (s-Cr ≥ 2mg/dL)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24725169
    Citation
    Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13.
    Results Reference
    derived

    Learn more about this trial

    Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

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