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

Samsung Medical Center

Status: Unknown

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: placebo; Drug: tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00954889

2009-05-004

Details and patient eligibility

About

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).

Full 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 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).

Enrollment: 220 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Tamsulosin

Experimental group

Treatment:

Drug: tamsulosin

placebo

Placebo Comparator group

Treatment:

Drug: placebo