Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 26, 2011
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 2, 2011
July 1, 2011
2 years
July 26, 2011
July 30, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
4 weeks and 12 weeks of treatment
Changes of parameters in voiding diary after 4 and 12 weeks treatment.
4 weeks and 12 weeks of treatment
Study Arms (2)
Tamsulosin 0.4mg
EXPERIMENTALtamsulosin 0.2mg
ACTIVE COMPARATORInterventions
Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
Eligibility Criteria
You may qualify if:
- Severe LUTS : IPSS ≥ 20
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13.
PMID: 24725169DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 26, 2011
First Posted
July 28, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
August 2, 2011
Record last verified: 2011-07