Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203371

Enrollment

Registered

2010-09-16

Start date

2011-01-01

Completion date

2012-01-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperplasia

Keywords

naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS

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 prostatic hyperplasia.

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

Interventions

DRUGNaftopidil

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

DRUGTamsulosin

0,4 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
International Prostate Symptom Score	2, 4, 8 and 12 weeks

Secondary

Measure	Time frame
Adverse Effect	2, 4, 8 and 12 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026