Benign Prostatic Hyperplasia Clinical Trial
Official title:
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg
The purpose of this study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).
Alpha-adrenoreceptor antagonists have become the primary medical treatment for lower urinary
tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The next treatment
method is trans-urethral resection of prostate (TURP). TURP is the most efficient BPH
treatment for relieving symptoms and improving uroflow, but it is also the invasive and
morbid.
Tamsulosin has higher selectivity for the pharmacological a1-adrenoceptor subtype and the
cloned a1a subtype than for the a1b subtype. Tamsulosin 0.4 mg improved Qmax to a slightly
greater extent than alfuzosin 10 mg.(26% and 16% versus baseline, respectively)(http://www.
fda.gov/cder/approval/ index.htm;accessed October 27, 2003.) and Tamsulosin 0.4 mg o.d. has
been reported to be well tolerated irrespective of age and/or cardiovascular
comorbidity/co-medication (Michel et al 1998) and no interaction with several
antihypertensive agents has been reported. (Lowe et al. 1997) Our study is to explore the
efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH
refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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