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

NCT ID: NCT01404637

Last Updated: 2011-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tamsulosin 0.4mg

Group Type EXPERIMENTAL

Tamsulosin 0.4mg

Intervention Type DRUG

Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.

tamsulosin 0.2mg

Group Type ACTIVE_COMPARATOR

Tamsulosin 0.2mg

Intervention Type DRUG

tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.

Interventions

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Tamsulosin 0.4mg

Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.

Intervention Type DRUG

Tamsulosin 0.2mg

tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

References

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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.

Reference Type DERIVED
PMID: 24725169 (View on PubMed)

Other Identifiers

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2011-02-052

Identifier Type: -

Identifier Source: org_study_id

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