Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Sex: Male

Ages: 50 Years – 90 Years

Healthy volunteers: No

Phase: PHASE3

Sponsor: Apsen Farmaceutica S.A.

Location: Hospital das Clínicas da Faculdade de Medicina da USP São Paulo São Paulo

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 prostatic hyperplasia.

Eligibility Criteria

Inclusion Criteria: * Men ≥ 50 years * Signs and symptoms of BPH * IPSS of ≥ 10 * Prostate volume of ≥ 20 mL * PVR \> 150 mL Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01203371). StuddyBuddy aggregates publicly available trial information.