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 because the information has not been verified recently.
Verified July 2011 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
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

July 26, 2011
July 30, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.
 
Not yet recruiting
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)
Male
45 Years to 80 Years
Yes
Not Provided
 
NCT01404637
2011-02-052
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