Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

Samsung Medical Center

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tamsulosin 0.2mg; Drug: Tamsulosin 0.4mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01404637

2011-02-052

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Tamsulosin 0.4mg

Experimental group

Treatment:

Drug: Tamsulosin 0.4mg

tamsulosin 0.2mg

Active Comparator group

Treatment:

Drug: Tamsulosin 0.2mg