Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)