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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404637
Recruitment Status : Unknown
Verified July 2011 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2011
Last Update Posted : August 2, 2011
Information provided by:
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Tamsulosin 0.4mg Drug: Tamsulosin 0.2mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
Study Start Date : July 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tamsulosin 0.4mg Drug: Tamsulosin 0.4mg
Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.

Active Comparator: tamsulosin 0.2mg Drug: Tamsulosin 0.2mg
tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Changes of parameters in voiding diary after 4 and 12 weeks treatment. [ Time Frame: 4 weeks and 12 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sung Won Lee MD, Ph.D, Samsung Medical Center Identifier: NCT01404637     History of Changes
Other Study ID Numbers: 2011-02-052
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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