Status:
UNKNOWN
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Samsung Medical Center
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45-80 years
Phase:
NA
Brief Summary
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 prosta...
Eligibility Criteria
Inclusion
- Severe LUTS : IPSS ≥ 20
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01404637
Start Date
July 1 2011
End Date
October 1 2013
Last Update
August 2 2011
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