Status:
WITHDRAWN
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
Lead Sponsor:
Apsen Farmaceutica S.A.
Conditions:
Hyperplasia
Eligibility:
MALE
50-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign ...
Detailed Description
Inclusion Criteria: Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL
Eligibility Criteria
Inclusion
- Men ≥ 50 years
- Signs and symptoms of BPH
- IPSS of ≥ 10
- Prostate volume of ≥ 20 mL
- PVR \> 150 mL
Exclusion
- History of allergy to a AR antagonists
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01203371
Start Date
January 1 2011
End Date
January 1 2012
Last Update
February 8 2023
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, Brazil, 05403-010