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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: tamsulosin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br> | Drug: tamsulosin<br>* Treatment: tamsulosin 0.2mg, 2T /day Posology: two 0.2 mg tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* (tamsulosin 0.2mg + placebo)/day Posology: two tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the efficacy of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T)in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T) |  | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy on maximal flow rate and post-voided residual urine To evaluate efficacy on voiding frequency , nocturia To explore the tolerability and safety |  | 4 weeks and 12 weeks of treatment |