Status:
UNKNOWN
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg
Lead Sponsor:
Samsung Medical Center
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
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).
Detailed Description
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 tran...
Eligibility Criteria
Inclusion
- Male ≥ 45years
- (LUTS/BPH patients refractory to tamsulosin 0.2mg during 4 weeks)
- \*All of the following:
- Moderate to severe LUTS : IPSS ≥ 13
- An enlarged prostate (≥ 20mL, or moderately enlarged)
- Decreased peak flow rate : Qmax ≥4ml/s, ≤15mL/s volume voided ≥ 125 mL)
Exclusion
- Post voided residual urine ≥ 200mL
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00954889
Start Date
August 1 2009
Last Update
November 1 2011
Active Locations (1)
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1
Department of Urology, Samsung Medical Center
Seoul, Seoul, South Korea, 135-710