Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Tamsulosin 0.4mg (Drug); Tamsulosin 0.2mg (Drug)
Status: Not yet recruiting
Sponsored by: Samsung Medical Center
The purpose of this study is to compare the efficacy and safety of tamsulosin 0. 4mg (Harnal®
D. 0. 2mg, 2T) with tamsulosin 0. 2mg (Harnal® D 0. 2mg, 1T) in patients with severe
symptomatic benign prostatic hyperplasia as a first line therapy.
Official title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (HarnalÂ® 0.2mg, 1T)
Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
Changes of parameters in voiding diary after 4 and 12 weeks treatment.
Minimum age: 45 Years.
Maximum age: 80 Years.
- Severe LUTS : IPSS â‰¥ 20
- Post voided residual urine â‰¥ 150mL
- 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 â‰¥ 2 times of normal range)
- Renal insufficiency (s-Cr â‰¥ 2mg/dL)
Locations and Contacts
Starting date: July 2011
Last updated: July 30, 2011