Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
NCT ID: NCT01203371
Last Updated: 2023-02-08
Study Results
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2011-01-01
2012-01-01
Brief Summary
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Detailed Description
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Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Naftopidil
0,25 mg (2 weeks) and 0,50 mg (10 weeks)
Naftopidil
0,25 mg (2weeks) and 0,50 mg (10 weeks)
Tamsusolin
0,4 mg/day
Tamsulosin
0,4 mg/day
Interventions
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Naftopidil
0,25 mg (2weeks) and 0,50 mg (10 weeks)
Tamsulosin
0,4 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signs and symptoms of BPH
* IPSS of ≥ 10
* Prostate volume of ≥ 20 mL
* PVR \> 150 mL
Exclusion Criteria
* Treatment with antiandrogen drugs
* Drugs with anticholinergic activity
* Significant history of orthostatic hypotension
* Concomitant neurological diseases
* Known or suspected neurogenic bladder dysfunction
* Carcinoma of the prostate or bladder
* Previous surgery for BPH or bladder neck obstruction
* History of recurrent UTI
* Concomitant active UTI
50 Years
90 Years
MALE
No
Sponsors
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Apsen Farmaceutica S.A.
INDUSTRY
Responsible Party
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Apsen
Locations
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Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Countries
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Other Identifiers
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BRA10APS001
Identifier Type: -
Identifier Source: secondary_id
APS 001/2010
Identifier Type: -
Identifier Source: org_study_id
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