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NCT Number: NCT01203371

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

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.

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Key information

Conditions

Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-010, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naftopidil

Drug

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

Tamsulosin

Drug

0,4 mg/day

Other names: SECOTEX

Primary outcomes

  1. International Prostate Symptom Score

    Time frame: 2, 4, 8 and 12 weeks

Secondary outcomes

  1. Adverse Effect

    Time frame: 2, 4, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 16, 2010
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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