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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01404637
Other study ID # 2011-02-052
Secondary ID
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


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
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