Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Phase 3WithdrawnNCT01203371

Apsen Farmaceutica S.A.

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hyperplasia

Interventions

NaftopidilDRUG

0,25 mg (2weeks) and 0,50 mg (10 weeks)

TamsulosinDRUG

0,4 mg/day

Eligibility

Sex: MALEMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

International Prostate Symptom Score

Time frame: 2, 4, 8 and 12 weeks

Secondary Outcomes

Adverse Effect

Time frame: 2, 4, 8 and 12 weeks

Data from ClinicalTrials.gov

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