Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatments tamsulosin, placebo
Sponsor Samsung Medical Center
Start date August 2009
End date November 2011
Trial size 220 participants
Trial identifier NCT00954889, 2009-05-004

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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)
(Placebo Comparator)
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)

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 45 years old.

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)

Additional Information

Official title Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg
Principal investigator Sung Won Lee, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Samsung Medical Center.