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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01404637
• Other study ID #: 2011-02-052
• Status: Not yet recruiting
• Phase: N/A
• First received: July 26, 2011
• Last updated: July 30, 2011
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin 0.4mg
Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
• Tamsulosin 0.2mg
tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		12 weeks of treatment	Yes
Secondary	Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.		4 weeks and 12 weeks of treatment	Yes
Secondary	Changes of parameters in voiding diary after 4 and 12 weeks treatment.		4 weeks and 12 weeks of treatment	Yes