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

Overview

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.

Full Title of Study: “The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2013

Interventions

  • Drug: Tamsulosin 0.4mg
    • Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
  • Drug: Tamsulosin 0.2mg
    • tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.

Arms, Groups and Cohorts

  • Experimental: Tamsulosin 0.4mg
  • Active Comparator: tamsulosin 0.2mg

Clinical Trial Outcome Measures

Primary 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)
    • Time Frame: 12 weeks of treatment

Secondary Measures

  • 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
  • Changes of parameters in voiding diary after 4 and 12 weeks treatment.
    • Time Frame: 4 weeks and 12 weeks of treatment

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 45 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Sung Won Lee MD, Ph.D, Samsung Medical Center

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