Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

This study is not yet open for participant recruitment.

Verified July 2011 by Samsung Medical Center

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01404637

First received: July 26, 2011

Last updated: July 30, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 26, 2011
Last Updated Date	July 30, 2011
Start Date ^ICMJE	July 2011
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 27, 2011)	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 (Harnal® 0.2mg, 1T) [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01404637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 27, 2011)	Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment. [ Time Frame: 4 weeks and 12 weeks of treatment ] [ Designated as safety issue: Yes ] Changes of parameters in voiding diary after 4 and 12 weeks treatment. [ Time Frame: 4 weeks and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
Official Title ^ICMJE	The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Benign Prostatic Hyperplasia
Intervention ^ICMJE	Drug: Tamsulosin 0.4mg Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal. Drug: Tamsulosin 0.2mg tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
Study Arm (s)	Experimental: Tamsulosin 0.4mg Intervention: Drug: Tamsulosin 0.4mg Active Comparator: tamsulosin 0.2mg Intervention: Drug: Tamsulosin 0.2mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	October 2013
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Severe LUTS : IPSS ≥ 20 Exclusion Criteria: Post voided residual urine ≥ 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 ≥ 2 times of normal range) Renal insufficiency (s-Cr ≥ 2mg/dL)
Gender	Male
Ages	45 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01404637
Other Study ID Numbers ^ICMJE	2011-02-052
Has Data Monitoring Committee	Not Provided
Responsible Party	Sung Won Lee MD, Ph.D, Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samsung Medical Center
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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