Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apsen Farmaceutica S.A.
• Treatments: Naftopidil; Tamsulosin

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