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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404637
First Posted: July 28, 2011
Last Update Posted: August 2, 2011
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.
Information provided by:
Samsung Medical Center
July 26, 2011
July 28, 2011
August 2, 2011
July 2011
July 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01404637 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • 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.
  • Experimental: Tamsulosin 0.4mg
    Intervention: Drug: Tamsulosin 0.4mg
  • Active Comparator: tamsulosin 0.2mg
    Intervention: Drug: Tamsulosin 0.2mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
October 2013
July 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
45 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01404637
2011-02-052
Not Provided
Not Provided
Not Provided
Sung Won Lee MD, Ph.D, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP