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

This study is not yet open for participant recruitment.
Verified July 2011 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01404637
First received: July 26, 2011
Last updated: July 30, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Benign Prostatic Hyperplasia
 Drug: Tamsulosin 0.4mg
Drug: Tamsulosin 0.2mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

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) [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
  • Changes of parameters in voiding diary after 4 and 12 weeks treatment. [ Time Frame: 4 weeks and 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sung Won Lee MD, Ph.D, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01404637     History of Changes
Other Study ID Numbers: 2011-02-052
Study First Received: July 26, 2011
Last Updated: July 30, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013