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

Last updated: October 31, 2011
Sponsor: Samsung Medical Center
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Prostate Disorders

Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT00954889
2009-05-004
  • Ages > 45
  • Male

Study 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).

Eligibility Criteria

Inclusion

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

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)

Study Design

Total Participants: 220
Study Start date:
August 01, 2009
Estimated Completion Date:

Study 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).

Connect with a study center

  • Department of Urology, Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

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