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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00954889
First received: August 5, 2009
Last updated: October 31, 2011
Last verified: October 2011

August 5, 2009
October 31, 2011
August 2009
November 2011   (final data collection date for primary outcome measure)
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) [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00954889 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 4 weeks and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

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).

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • Drug: tamsulosin
    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)
  • Drug: placebo
    (tamsulosin 0.2mg + placebo)/day Posology: two tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)
  • Experimental: Tamsulosin
    Intervention: Drug: tamsulosin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
Not Provided
November 2011   (final data collection date for primary outcome measure)

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)
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00954889
2009-05-004
Not Provided
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Sung Won Lee, MD Samsung Medical Center
Samsung Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP